Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care

The Effects Of Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care On Healthy Lifestyle Behaviors And İn Vitro Fertilization (IVF) Success İn Women With Primary Infertility

Infertile individuals frequently attempt behavioral changes to enhance the effectiveness of their treatment and improve fertility outcomes. Consequently, this study was designed to assess the impact of fertility supportive behavior education, grounded in Watson's Human Care Theory, on healthy lifestyle behaviors and the success rates of in vitro fertilization (IVF) in women with primary infertility

Study Overview

• Status: Completed
• Conditions: Infertility, Female; IVF
• Intervention / Treatment: Behavioral: Fertility supportive behavior education based on Watson's Theory of Human Care; Procedure: Routine nursing care; Device: The booklet "Fertility-Supporting Health Training

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Gaza, Palestinian Territory, occupied
    • Albasma a private IVF center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women have a diagnosis of primary infertility.
• Women over the age of 18 and under the age of 32.
• Women able to read and write in Arabic.
• The cause of infertility must be a male factor.
• Women who are undergoing assisted reproductive techniques, specifically İn Vitro Fertilization-Intracytoplasmatic Sperm Injection.
• Women using the same drugs and protocols for IVF treatment.
• Only women who receive a fresh embryo transfer during their IVF treatment included in the study.

Exclusion Criteria:

• Women who have problems with understanding or perception
• The presence of tubal, uterine or other infertility factors in women
• Women undergoing a frozen embryo transfer as part of their IVF treatment
• Women whose pregnancies do not continue or who are diagnosed with a fetal anomaly by the time the healthy lifestyle behaviors scale is re-administered after 3 months excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; The intervention group received fertility supportive behavior education based on Watson's Theory of Human Caring and was given a booklet titled 'Fertility-Supporting Health Training' at the onset of treatment. In addition to routine nursing care, the researcher provided detailed intervention and guidance regarding the booklet throughout the treatment period.	Behavioral: Fertility supportive behavior education based on Watson's Theory of Human Care; In this study, Watson's Theory of Human Caring guided the development of a care framework and nursing intervention for women with infertility. The researchers adapted the theory and focused on six of the ten carative factors : 1) Adopting values of humanity and devotion; 4) Developing supportive care relationships; 6) Using problem-solving methods for informed decisions; 7) Tailoring teaching to individual needs; 8) Creating a comfortable, peaceful environment; 9) Assisting with basic needs. The nursing care program, integrated with IVF treatments (14-18 days), involved four transpersonal interviews lasting 45-90 minutes each. These interviews were recorded in notes, used to individualize future sessions. The approach included active listening, empathy, and support, with participants encouraged to keep diaries for discussion. Communication was maintained in person, by phone, or email.; Procedure: Routine nursing care; Routine nursing care during IVF treatment includes: Pre-Treatment Counseling: Providing information and addressing patient questions. Monitoring and Assessment: Regular checks of health, hormone levels, and ovarian function. Medication Administration: Giving prescribed fertility drugs and other medications. Assisting with Procedures: Preparing and assisting with egg retrieval and embryo transfer. Emotional Support: Offering emotional and psychological support. Education: Instructing on medication use, self-care, and recognizing complications. Follow-Up Care: Scheduling and managing follow-up appointments to monitor progress; Device: The booklet "Fertility-Supporting Health Training; This booklet was prepared in line with the relevant literature and contained educational content aimed at improving healthy lifestyle behaviours . The training booklet included information on the effects of factors such as obesity, weakness, exposure to environmentally harmful substances, smoking and caffeine use on fertility and the methods of coping with these factors. In addition, information on how to use proper nutrition, develop exercise habits and cope with stress was provided. The booklet was distributed to the women at at the onset of the study.
Other: control group; The control group received routine nursing care and was given a booklet titled 'Fertility-Supporting Health Training' at the onset of treatment, but the researcher did not provide any additional intervention or guidance regarding the booklet.	Procedure: Routine nursing care; Routine nursing care during IVF treatment includes: Pre-Treatment Counseling: Providing information and addressing patient questions. Monitoring and Assessment: Regular checks of health, hormone levels, and ovarian function. Medication Administration: Giving prescribed fertility drugs and other medications. Assisting with Procedures: Preparing and assisting with egg retrieval and embryo transfer. Emotional Support: Offering emotional and psychological support. Education: Instructing on medication use, self-care, and recognizing complications. Follow-Up Care: Scheduling and managing follow-up appointments to monitor progress; Device: The booklet "Fertility-Supporting Health Training; This booklet was prepared in line with the relevant literature and contained educational content aimed at improving healthy lifestyle behaviours . The training booklet included information on the effects of factors such as obesity, weakness, exposure to environmentally harmful substances, smoking and caffeine use on fertility and the methods of coping with these factors. In addition, information on how to use proper nutrition, develop exercise habits and cope with stress was provided. The booklet was distributed to the women at at the onset of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Health-Promoting Lifestyle Profile II instrument	The Health-Promoting Lifestyle Profile II (HPLP-II) is a widely-used instrument for evaluation of health behaviour which has been validated in multiple studies. Based on Pender's Health Promotion Model, it conceptualises an individual's health-promoting lifestyle in terms of the following dimensions; health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations and stress management.	Both groups completed a Health-Promoting Lifestyle Profile instrument and pre-test measures, at the onset of the study. At the end of treatment after embryo transfer they were administered test measures.After 3 months were administered posttest measure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A quantitative human chorionic gonadotropin (HCG or hCG) blood test	A quantitative human chorionic gonadotropin (HCG or hCG) blood test measures the specific level of HCG in the blood. HCG is a hormone produced in the body during pregnancy. Results are given in milli-international units per milliliter (mUI/mL). Normal levels are found in: Non-pregnant women: less than 5 milli-international units per milliliter Healthy men: less than 2 milli-international units per milliliter	14 days after embryo transfer

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: September 8, 2024
• First Submitted That Met QC Criteria: September 8, 2024
• First Posted (Estimated): September 11, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Fertility; Nursing Care; Lifestyle; Watson's Human Caring Theory
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 1241/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No