INTRODUCTION:

Background of the Study

Parenthood is a fundamental human need. The urge to reproduce is universal. Every human being has a desire to become a parent and look after his or her children. The very desire for parenthood is a step in the direction of creating a family. Fertility or the ability to reproduce children has a positive social value where as, infertility has a negative value in Indian culture. Today fertility and infertility have both emerged equally problematic in the world population context. Most fertile couples around 90% should get pregnancy, within a year of regular intercourse. This rises to 95% over a two-year period.

The WHO has defined infertility as the inability to achieve a pregnancy after one year of unprotected intercourse. When a woman has never conceived, despite sexual relation for a period of one year, it is primary infertility. When a woman has previously conceived and is subsequently unable to conceive, despite sexual relation for a period of one year, it is secondary infertility. According to this criterion 20% of couples are infertile though this falls to 10% after 18 months.

It is estimated that about 8%–10% of couples experience some sort of infertility in their reproductive lives. In India, primary and secondary infertility figures, as given in WHO studies, are 3% and 8%, respectively. A report available at the WHO library explains primary and secondary infertility affects 8-12% couples (50-80 million) worldwide.

\According to National Survey of family growth, 1.2 million (2% of 10 million) woman of reproductive age had an infertility related medical appointment and an additionally 23% received infertility services sometimes in their lives. Approximately 1/6^th of marriages are involuntarily depends on how the complaints is defined.

Overall 7% of currently married women in India were childless, Southern (10.9%) and Western (10.7%) region shows highest percentage of women followed by Eastern region (6.5%). However Central region exhibits lowest (4.7%) of childlessness. Andhra Pradesh shows highest percentage of childless women (13.3%) in India followed by Goa (11.8%). Urban areas have more percentage of childless women than their rural counterparts. Results reveal that age is negatively associated with childlessness.

A community-based survey was done in an urban slum covering 7620 populations. The prevalence of primary infertility was 3.27%. Majority of woman with problems of infertility had problems of ill treatment to avail services from government hospital but only 42.87% complied with the treatment, major obstacle being non-cooperation from husband.

Need for the study

Pregnancy and childbirth usually take their normal course, and a healthy baby is born without problems. But some less fortunate couples are unable to fulfill their dream of having the desired baby because of infertility. Imagine the anguish of a married couple who desperately want to have a child yet because of infertility cannot. They look to medical science for help and that many techniques and therapies have been developed to overcome infertility. Women initiate most fertility inquiries because they see physicians more frequently and because social norms assign them greater reproductive responsibility.

An estimated one in ten couples around world has difficulty conceiving at some point in their reproductive lives. Nearly 5.3 million American women are infertile; representing 9.1% of all women aged 15 to 44. Infertility affects 15 to 20% of all couples who are trying to conceive. The problem may be associated with male factors (40%) or both (10-15%) are unexplained.

Evidence from a village-level study in the state of Maharashtra in India puts the level of infertility at 6%–7%. According to the recent National Family Health Survey in India, 3.8% of women between the ages of 40 and 44 years have not had any children and 3.5% of currently married women are declared infecund.

Considering magnitude of problems of infertility and its consequences on couples like, the feelings of disbelief and denial, feeling of frustration, anger and anxiety, these seems to be a huge unmet demand for appropriate management of these problems. Childlessness causes couples to perceive a sense of loss in relationship, in health status, prestige, self-esteem, self-confidence, security and perceived loss of something of symbolic value.

Nursing practice is direct, goal oriented and adaptable to the needs of the individual, family, and Community during health and illness. Meaning of caring in Nursing has increased. Graber and Mitcham (2004) sought to identify actions, interventions, and interpersonal relationships that demonstrated caring and compassion.

The researcher has come across many infertile women undergoing intrauterine insemination. These groups if been utilizing the health care unit effectively would have helped them in fulfilling their wish of giving birth to a baby. A nurse can effectively provide care during infertile women undergoing Intra uterine insemination.

Hence, the investigator felt the need to implement clinical pathway for infertile women undergoing Intra uterine insemination influencing utilization of health services provided by nurses. No similar study was done in this subject by nurses and in the selected study would help in developing a better understanding and provide baseline information on the clinical pathway improve the patient care and Increase the knowledge and practice of nurses for infertile women undergoing intra uterine insemination. The investigator interested to assess the effectiveness of clinical pathway for infertile women undergoing intra uterine insemination.

Statement of the Problem

A Quasi Experimental Study to Assess the Effectiveness of Clinical Pathway for Infertile Women undergoing Intra Uterine Insemination upon the Knowledge and Practice of Nurses and Patient Outcome at Apollo Hospital, Chennai.

Objectives of the Study

1. To assess the pre test and post test level of knowledge and practice of nurses regarding clinical pathway for infertile women undergoing intra uterine insemination.

2. To evaluate the effectiveness of clinical pathway for infertile women undergoing intra uterine insemination upon the knowledge and practice of nurses.

3. To assess and compare patients outcome in control and experimental group of infertile women.

4. To determine the level of satisfaction upon nursing care control and experimental group of infertile women.

5. To determine the association between the selected demographic variables of nurses with their pre and post test level of knowledge regarding clinical pathway for intra uterine insemination.

6. To determine the association between the selected demographic variables with patient outcome and level of satisfaction in control and experimental group of infertile women.

7. To determine the association between the selected clinical variables with patient outcome and level of satisfaction in control and experimental group of infertile women.

8. To determine the association between the selected psychosocial variables with patient outcome and level of satisfaction in control and experimental group of infertile women.

Assumptions

The study assumed that

· Infertility treatment is expensive and challenging procedure which needs holistic approach to succeed conception.

· Health care aspect is multi disciplinary approach and focused on quality care.

· Systematic managed care will reduce the hospital stay and improve treatment outcome.

· Proper clinical pathway is a base for developing holistic comprehensive care plan for the patient.

· Clinical pathway has implications for nurse patient relationship and plays a key role of nurse among health care personnel to implement the effective care.

Null Hypotheses

Ho₁There will be no significant difference between pre and post test level of knowledge and practice of nurses regarding clinical pathway for infertile women undergoing intra uterine insemination

Ho₂There will be no significant difference in the patient outcome and level of satisfaction between the control and experimental group regarding clinical pathway for infertile women undergoing intra uterine insemination.

Ho₃There will be no significant association between the selected demographic variables of nurses and the pre and post test level of knowledge and practice regarding clinical pathway for infertile women undergoing intra uterine insemination.

Ho₄There will be no significant association between the selected demographic variables of control and experimental group of infertile women undergoing intra uterine insemination and patient outcome regarding clinical pathway.

Ho₅There will be no significant association between the selected clinical variables of control and experimental group of infertile women undergoing intra uterine insemination and patient outcome regarding clinical pathway.

Ho₆There will be no significant association between the selected psychosocial variables of control and experimental group of infertile women undergoing intra uterine insemination and patient outcome regarding clinical pathway.

Conceptual framework-Modified Rosentoch (1974) and Becker’s Health Belief Model (1978)

It deals with the interrelated concepts of abstractions that are assembled together in some rational scheme by virtue of their relevance to common theme. Conceptual models are models made up of concepts, which describe the mental images of a phenomenon and integrate them into a meaningful configuration. The conceptual frame work gives the idea to the researcher’s main view and core theme of the research i. e. it is a visual diagram by which the researcher explains the specific area of interest.

The conceptual framework for the study is based on Health Belief Model. Health Beliefs are person’s ideas and attitude, about health and illness. They may be based on factual information or wrong information. The health belief usually results from within a person. So, the investigator felt the Becker’s model is suitable as conceptual framework for this study, to assess the knowledge of nurses regarding clinical pathway for infertile women undergoing intra uterine insemination.

Rosentoch (1974) and Becker’s Health Belief Model (1978), address the relationship between a person’s belief and behaviors, it is way of understanding and predicting how clients will behave in relation to their health and how they will comply with health care therapies. Use of model is based on a person’s perception of susceptibility to an illness and resources of illness. This model helps nurses to understand dimensions and steps for clinical pathway for infertile women undergoing Intra uterine insemination, in order to provide the most effective care. The model describes about three variables

1. Nurse’s perception Knowledge clinical pathway for infertile women undergoing Intra uterine insemination.

2. Modifying factors Demographic variables of nurses and patients, clinical variables and psycho social variables of infertile women, Clinical pathway Structured knowledge questionnaire, Practice check list for nurses, Satisfaction scale and outcome check list for patient.

3. Likelihood of taking an actionThis part indicates nurse will gain knowledge on clinical pathway and improve the practice and infertile women satisfaction and improve patient outcome by improving effective and holistic care to infertile women undergoing Intra uterine insemination.

RESEARCH METHODOLOGY

Research Approach

In this study the investigator wanted to assess the effectiveness of clinical pathway for infertile women undergoing intra uterine insemination, the quasi experimental approach seemed to be the most appropriate approach.

Research Design

A one group pre-test and post-test, which is Quasi-experimental in nature, was adopted for conducting the study. In this study, the investigator administered pre-test for the selected nurses and the investigator manipulated the independent variables i.e. administration of clinical pathway for the same group of nurses and the post test was conducted.

The research design of One Group Pre and Post-test for Nurses is represented diagrammatically as follows:

O₁ X O₂

O₁ --- Pre-test to assess the knowledge of nurses regarding clinical pathway for infertile women undergoing intrauterine insemination.

X --- Structured teaching on clinical pathway for infertile women undergoing intrauterine insemination.

O₂--- Post-test to assess the gained knowledge of nurses regarding clinical pathway for infertile women undergoing intrauterine insemination.

The Quasi-experimental research design for Infertile Women is represented diagrammatically as follows:

- O₁

X O₁

X --- Implementation of clinical pathway for infertile women undergoing intrauterine insemination.

O₁ --- Observation of level of satisfaction and the patient outcome for infertile women undergoing intrauterine insemination.

Research Setting of the Study

The study was conducted in the Apollo hospital, Chennai.

Population

In this study, the target population comprises of all infertility couples undergoing Intra uterine insemination. The accessible population in this study was Nurses working in IUI unit and Infertile women undergoing intra uterine insemination at Apollo Hospital, Chennai.

Sample

A sample of 60 infertile women undergoing treatment of Intra uterine insemination in Apollo hospital Chennai, was selected for the study out of which 30 were assigned to Control group and 30 were assigned to Experimental group of infertile women.

Sampling Technique

The subject of the study selected by purposive sampling.

Sampling Criteria

Inclusion criteria

The study includes patient who

Ø Were infertile women undergoing treatment of Intra uterine insemination.

Ø Were infertile women who are conscious and willing to participate in the study.

Ø Were Infertile women who speak and understand English and Tamil

Ø Were Nurses working in infertility treatment unit

Ø Were Nurses who are willing to participate in study

Exclusion criteria

The study excluded

Ø Infertile women who are not willing to participate in the study

Ø Nurses who are not willing to participate

Selection and Development of Study Instruments

The instruments used were Demographic variable proforma of infertile women and nurses, Clinical and Psychosocial variable proforma of infertile women, structured knowledge questionnaire, Practice check list for nurses and Satisfaction scale and Patients outcome proforma for infertile women

Psychometric Properties of the Instruments

Validity of the Instruments

Content validity of the tool was obtained from seven experts in the field of Obstetrics and Gynaecology. Two of the experts were doctors and five were nursing personnel. The suggestions given by the validators regarding rating scale was made in the final preparation of the tool.

Reliability

Reliability is the degree of consistence or dependability with which an instrument measures an attribute (Polit 2010). The reliability of the tools was determined by using split half method and inter rater technique. Karl Pearson’s ‘r’ was computed for finding out the reliability.

Pilot Study

Pilot study was conducted with five infertile women undergoing Intra uterine Insemination who come to Prashanth Fertility Research Centre, Chetpet, Chennai. The purpose was to find out the feasibility and practicability of the design. The structured knowledge questionnaire and clinical pathway were administered and found to be feasible on the whole, clinical pathway was found to be feasible.

Development of Clinical pathway

Clinical pathway was prepared based on patient’s need followed Henderson’s theory and based on activities by the investigator with an approval of objectives , Care pathway and day care from day one to follow up care. It included clinical pathway, investigation, ovulation, medication and procedure. The staff nurse instructed to follow the clinical pathway for providing care for infertile women undergoing intra uterine insemination. The prepared clinical pathway was distributed to the experts in the field of obstetrics and gynecology for establishing content validity. The content was modified according to the expert advice.

Data Collection Procedure

Data collection is the precise, systematic gathering of information relevant to the research purpose. The researcher presented the proposal to the ethical committee of Apollo Hospitals and got ethical clearance was obtained to proceed the study. The investigator collected the data from Apollo Hospital, Chennai after obtaining formal permission from concerned authorities. The observation time schedule was from 9 am –5.00pm from Monday to Saturday.

A group of 4 nurses were selected from ART unit by purposive sampling technique and obtained verbal consent for the study participants. Collected the baseline data by using demographic variable proforma .Their pretest knowledge level was assessed by using structured knowledge questionnaire on clinical pathway for Intra uterine Insemination.

The control group of 30 infertile women undergoing Intra uterine Insemination was selected by purposive sampling method. Baseline data was collected by using demographic, Clinical variable proforma and psychosocial proforma, after obtaining a consent from them. Nursing care received by infertile women undergoing Intra uterine Insemination was assessed by using practice checklist through participatory observation method. After the IUI procedure rating scale on satisfaction of nursing care was distributed and their level of satisfaction was assessed.

The clinical pathway for infertile women undergoing Intra uterine Insemination was educated to same group of nurses and the doubts of nurses were cleared. The nurses were then instructed to use the clinical pathway from the during their treatment period. After one week the investigator assessed the post test knowledge level of same group of nurses.30 infertile women undergoing Intra uterine Insemination were selected for the experimental group. After obtaining a consent, pathway was placed in their files and baseline data was collected by using demographic, clinical Psycho social variable proforma. Nursing care of these infertile women was assessed by using practice checklist upon the nurses by participatory observation method. After their IUI procedure rating scale on satisfaction of nursing care was distributed and their level of satisfaction was assessed. Patient outcome assessed through phone conversation for their success in conception after 21 days of IUI procedure of control and experimental group of infertile women.

The problems faced during the process of the data collection were

Ø The infertile women coming for outpatient department can’t observe completely.

Ø Some of the infertile women showed unwillingness to participate in the study.

Ø Nurses are involving taking care of other infertile women with treatment such as IVF, ICSI and HRT etc.

Plan for data analysis

Descriptive statistics like frequency distribution, percentage, mean, standard deviation and inferential statistics like paired ‘t’ test were used to analyze the data.

Comparison of Mean and Standard Deviation Level of Satisfaction in Control and Experimental group of infertile women

Satisfaction	Mean	Standard deviation	‘t’ Value
Control group (n=30)	43.43	3.11	-
Experimental group(n=30)	88.23	5.33	-
Improvement	44.80	2.22	40.39***

***P < 0.001

It was observed from Table 1 that mean and standard deviation of level of satisfaction of infertile women were low in the control group of infertile women (M= 43.3, SD= 3.11) in comparison (M= 88.23,SD= 5.33) to the experimental group of infertile women. This shows that the patient’s satisfaction improved after administering clinical pathway. The result was statically significant at 99.9% level of significance. Hence the Ho₂null hypothesis is rejected.

Comparison of Mean and Standard Deviation Patient outcome in Control and Experimental group of Infertile Women

Patient outcome	Mean	Standard deviation	‘t’ Value
Control group (n=30)	0.73	0.888	-
Experimental group (n=30)	0.83	0.960	-
Improvement	0.1	0.072	0.420

It was observed from Table 1 that mean and standard deviation of Patient outcome of infertile women were low in the control group of infertile women (M= 0.73, SD= 0.888) in comparison (M= 0.83, SD=0.960) to the experimental group of infertile women. This shows that the patient’s satisfaction improved after administering clinical pathway.

CONCLUSION:

The findings of this study indicate that the clinical pathway enhanced the knowledge of the nurses . It is suitable method of tool for the nurses to provide quality care for infertile women undergoing intra uterine Insemination. Clinical pathway is necessary to improve the knowledge of nurses for providing cost effective care by providing quality care for success in conception. An improvement of knowledge level of nurses will lead to better practices, reducing variance and provide quality care.

Implications

Nursing practice

The infertile women of the experimental group felt increased satisfaction regarding care provided by nurses after implementing clinical pathway than the control group proving it to be effective to use. As clinical pathway is an important nursing responsibility to follow and provide care by saving time, cost effective care and quality care. As the study found (M=49.30 and SD= 0.35) improvement after implementing clinical pathway.

Nursing education

The nursing profession has a long history of viewing and caring for individuals in a holistic manner. Out of 100 couples trying to conceive naturally, 20 will conceive within one month, 70 will conceive within six months, 85 will conceive within a year , 90 will conceive within 18 months , 95 will conceive within two years Nobel prize .org(2010). In 1994, Speroff et al, stated that, The problem may be associated with male factor infertility (35% -45%) or female factors 40% or both. 10% -15% are unexplained. Inherent in the nurse’s role is the ability to assess, intervene and evaluate preventive, supportive, and restorative functions of a patient’s physical, emotional, mental and spiritual domains. This should be emphasized to the nursing students through educating them about the various diseases preparing clinical pathway and using to provide care that helps the patients in providing care to meet the above aspects.

Clinical Pathway for Infertile Women Undergoing Intrauterine Insemination

ASSESSMENT

1. History collection

1.1 Baseline information

1.2 Medical, surgical, gynaecological and obstetrical history.

1.3 Observe emotional and social impact on Infertility.

1.4 Education on sex life and ovulation.

2. Physical assessment

2.1 Head to foot assessment

2.2 Gynecological assessment

3. Investigations

Female

3.1 Complete blood count

3.2 Thyroid function test

3.3 FSH, LH and prolactin level.

3.4USG:

ü Day 2 and day 3 basal scan through transvaginal scan.

ü Follicular scan during ovulation period. (10^th day of menstruation- till rupture of follicles).

*Male

3.5 Semen analysis

4. Counselling

4.1 Allow the couple to participate in counselling.

4.2 Educate about causes of infertility.

4.3Advise about life style modification.

4.4 Ask about sexual life pattern.

4.5 Advise about types and choice of infertility treatment detail.

4.6 Educate about cost and expected outcome of Intra uterine insemination procedure.

4.7 Be attentive when counselling the couple.

4.8 Encourage the couple to ask any queries.

4.9 Allow the couple to ventilate their feelings.

5. Health Education

*For Female

5.1 Advice to take Folic acid 5mg daily and regularly

5.2 Advice the couple to avoid Stressful situation

5.3 Educate the couple balanced diet

5.4 Administration of Clomiphine citrate(first line drug) or Letrazole other drugs such as Human menopausal hormone , Bromocriptine orally for maturation of ovum

5.5 Timing and duration of drug intake .- Daily morning to take

5.6 Education about Oestrogen hyper stimulation syndrome symptoms such as nausea, dryness of mouth and skin, fainting and palpitation.

* For Male

5.7 Advice him to avoid stress in occupational area.

5.8 Educate him about avoiding of bad habits such as smoking, alcoholism and junk foods.

5.9 Advice him to take healthy diet, such as

· Protein rich diet

· Fibre rich diet

· Advice to avoid fat rich diet and junk foods.

5.10 Change in life style and occupation if needed.

6. Follicular Period ( 3 Days To Till Follicular Rupture )

Female:

6.1. Education regarding daily scanning,

*Every morning during ovulation period.

6.2 Administration of medication ( HCG ) when follicle reaches 20 x20 mm for rupture.

6.3 Maintenance of oral drug treatment of Folic acid0.5 mg per orally.

*Male:

6.4 Advice him to avoid sexual activity and masturbation for 3 -5 days before sample collection.

6.5 Educate him about collection of sample of semen.

* Advice him not to use of condom for collection of semen.

* Advice him to use wide mouth and sterile container.

PROCEDURE

7. Before Procedure

7.1 Educate about signs and symptoms of ovulation

*Pain in the flank region

*Nausea

*Increased basal body temperature 0.2 – 0.6 degree F.

7.2 Advised her to go for follicular study for detecting release of ovum in the morning.

7.3 Once the ovulation occurs, advice her partner to give semen specimen in the lab.

7.4 Preparation of articles for procedure

Articles are

* Sim’s vaginal speculum

* Allis forceps

* Gluco needle or IV cannula

* Semen container

* Syringe 1 ml

* Gloves

* Gauze

* Saline

* Kidney tray

7.5 Educate about position, deep breathing exercise during procedure

7.6 Positive attitude about success of procedure.

7.7 Collect the prepared 0.5ml semen sample from lab.

8. During Procedure

8.1 Explain about procedure

8.2 Cross Check the articles

8.3 Provide privacy and switch on the light

8.4 Assist for Lithotomy positioning and draping.

8.5 Provide prepared semen specimen to physician to take into cannula.

8.6 Assist to give instruments to visualize the cervix by Cosco’s speculum and allis forceps.

8.7 Encourage her to take deep breathing and relaxed.

9. After procedure

9.1 Provide comfortable (supine) position and cover with sheet.

9.2 After procedure advice her to lie down for 10 - 20 minutes.

9.3. Discard the used supplies.

9.4 Send the instruments for cleaning and sterilization.

10. Home care

10.1 Avoid Heavy lifting

10.2 Advice her to follow relaxation technique such as reading books and meditation etc.

10.3 Advice the couple to have sexual intercourse from next day of procedure day.

10.4 Positive attitude of conception

10.5 Educate about taking folic acid regularly

10.6 Advice her to insert Progesterone suppositories per vagina or oral tablets as per order.

10.7 Advice the couple to come for follows up after 21 days from procedure date, to test for pregnancy.

Nursing administration

With the advent of various technologies in the field of nursing, nurses are expected to be skillful in various aspects of providing care for which student nurses has to be trained in it through their education. Thus it is the responsibility of the nurse administrators to include the concept of clinical pathway in the nursing curricula. The nursing staffs and the nursing students should be encouraged by the nurse administrators to learn various nursing modalities in caring patients by using various protocols for various disease conditions.

Nursing research

There is need for extensive and intensive research in this area. It opens a big avenue for research on innovative methods of using clinical pathway for the development of good and effective method to render the quality care. The competence of a nurse to perform the skills of using tool for providing care begins with nursing education and ends with nursing practice which requires an evidence to give assurance that the knowledge and practice gained by the nurse are safe and provides comfort for the patients. Thus major research has to be promoted and conducted by the nurse researchers to prove the effectiveness of nursing care in nursing profession.

Nursing theory

The conceptual framework for the present study is based on Health Belief Model views Health Beliefs are person’s ideas and attitude, about health and illness. They may be based on factual information or wrong information. The health belief usually results from within a person. So, the investigator felt the Becker’s model is suitable as conceptual framework for this study, to assess the knowledge of nurses regarding clinical pathway for infertile women undergoing intra uterine insemination. This Model provide frame work to identify needs of the patients in an organized manner and it can be used to educate and guide the nurses.

Recommendations

Ø The same study can be conducted with larger number of samples.

Ø A comparison can be made between different health care settings.

Ø A comparison can be made with different group of infertile women treatment protocol.

Ø The same study can be conducted with different specialization of treatment protocol.

Ø A comparison can be made between different types artificial reproduction treatment.

REFERENCES:

· Aboulghar. M et.al.(2009) Intra uterine Insemination. Human reproduction updates 15(3). 265- 77.

· Badaway. A. et al. (2009) Fertilization Sterilization. Effect of Sperm morphology and number on success of Intrauterine insemination. 39(2):164-71.

· Basse. L (2000) A Clinical Pathway to Accelerate Recovery After Colonic Resection; Lippincott Williams and Wilkins, July, 51-57

· Belgan (2008) Journal of obstetrics and gynecology. A clinical pathway for reducing patient length of stay and resource utilization in tertiary-care academic medical center at USA. 21(8)209-11.

· Bere. K.S.J. (2008) Bereksand Navak’s Gynecology, 14^th Edition, Lippincott, New Delhi. 45-60.

· Berman. A. et al. (2008) Kozhier’s and ERb’s Fundamentals of Nursing Concepts Process and Practice. 8^th edition, Pearson Education in South Asia.11-13.

· Beutel .M.,Kuffer. J. (2007) Treatment related stresses and depression in Couples undergoing assisted reproductive treatment by IVF or ICSI. Journal of Obstetrics and Gynecology 26(8). 2084-91 Retrieved from www.sciencedirect. com assisted reproductive technology

· Boivin J Takefman J, Braverman A. (2011) Human Reproduction. The fertility quality of life (FertiQoL) tool development and general psychometric properties. 26 (8)2084-91.

Received on 06.06.2012 Modified on 18.08.2012

Asian J. Nur. Edu. and Research 2(3): July-Sept. 2012; Page 126-134