Swanson-Based Supportive Care for Infertility Stress and Coping in Couples Undergoing ART

A Swanson's Caring Theory-Informed Supportive Care Intervention for Reducing Infertility-related Stress and Improving Coping Strategies in Couples Undergoing Assisted Reproductive Treatment

The goal of this clinical trial is to learn if supportive care based on Swanson's Caring Theory can reduce stress and improve coping in couples undergoing infertility treatment with assisted reproductive treatment (ART), including in vitro fertilization (IVF).

Infertility can be emotionally challenging and may affect both partners. Many couples experience stress, uncertainty, and difficulty coping during treatment.

The main questions this study aims to answer are:

• Does this supportive care program reduce infertility-related stress in women and men?
• Does it improve how couples cope with the challenges of infertility treatment? Researchers will randomly assign (by chance) couples to one of two groups: a supportive care group or a routine care group.

All participants will continue their planned fertility treatment.

Participants will:

• Be randomly assigned to one of the two groups
• Receive either supportive care (education and counseling throughout treatment) or routine care
• Complete questionnaires about stress and coping before treatment, after the oocyte retrieval procedure, and one month after embryo transfer
• Couples who do not achieve pregnancy will complete one additional questionnaire Swanson's Caring Theory is a care approach that focuses on understanding individuals' experiences, providing emotional support, and helping people cope with difficult situations.

The results of this study may help improve structured supportive care for couples undergoing infertility treatment and promote more effective coping and lower stress during the treatment process.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Behavioral: Swanson Caring Theory-based supportive care

Detailed Description

Infertility is a significant life event that can affect individuals and couples at multiple levels, including emotional well-being, relationship dynamics, and future life planning. The World Health Organization defines infertility as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. Infertility-related stress often increases throughout the diagnostic and treatment process, and individuals undergoing ART frequently report elevated stress levels and difficulties in coping. Although infertility is experienced by both partners, supportive care interventions have largely focused on individuals, and structured approaches that include both partners remain limited.

Healthcare professionals, including midwives and nurses, are well positioned to provide continuous support during infertility treatment. Structured supportive care interventions may help reduce infertility-related stress and enhance coping; however, theory-informed and couple-inclusive care models are still limited in infertility treatment settings. Therefore, this single-blind randomized controlled trial was designed to evaluate the effects of a supportive care program based on Swanson's Caring Theory on infertility-related stress and coping in couples undergoing ART.

Swanson's Caring Theory was originally developed in the context of pregnancy loss and focuses on how caring processes support individuals in coping with loss, uncertainty, and emotional distress. The theory has since been applied across various clinical settings requiring supportive care. Unsuccessful assisted reproductive treatment may be perceived as a significant loss and can evoke grief-like responses. Therefore, this framework provides a relevant approach for supporting individuals undergoing infertility treatment.

Couples were randomly assigned to either an intervention group receiving structured education and counseling throughout the treatment process or a control group receiving routine care.

The sample size was determined based on the primary outcome, assuming 95% confidence, 95% statistical power, and an effect size of 0.60, resulting in a required sample size of 42 participants per group. To account for potential attrition, additional participants were included, leading to a total sample of 100 individuals (50 couples).

Data were collected at three time points: before treatment initiation, after oocyte retrieval, and one month after embryo transfer. For participants who did not achieve pregnancy, an additional follow-up assessment was conducted. The primary outcomes of the study were infertility-related stress and coping strategies.

Statistical analyses were performed using SPSS software (version 28). Descriptive statistics, including means, standard deviations, frequencies, and percentages, were used to summarize participant characteristics and outcome variables. For women and men, between-group comparisons at each assessment point were conducted using independent-samples t tests, and within-group changes between the first and second assessments were examined using paired-samples t tests. For participants with unsuccessful ART outcomes, third-assessment scores were compared between the intervention and control groups using independent-samples t tests. Statistical significance was set at p < 0.05.

The findings are expected to contribute to the development of structured, theory-informed supportive care approaches for couples undergoing infertility treatment.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Samsun, Turkey (Türkiye), 55200
    • Ondokuz Mayıs University Health Practice and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion Criteria:
• Couples diagnosed with primary infertility
• Aged 18 years or older
• Able to read and understand Turkish
• No diagnosed psychiatric disorder
• No communication problems or mental disability
• Scheduled to undergo assisted reproductive treatment (ART)
• Participation as a couple (both partners enrolled together)

Exclusion Criteria:

• - No oocytes obtained during oocyte retrieval
• No sperm obtained from the male partner
• No embryo available for transfer
• Discontinuation of treatment during the study process

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: Swanson-Based Supportive Care; Participants receive structured supportive care based on Swanson's Caring Theory, including education and counseling throughout the ART process.	Behavioral: Swanson Caring Theory-based supportive care; A structured supportive care program based on Swanson's Caring Theory, including seven sessions of education, counseling, and emotional support delivered by a midwife to infertile couples throughout the ART process. The program was integrated into key treatment stages (ovarian stimulation, oocyte retrieval, and embryo transfer) and included both face-to-face and online sessions, focusing on reducing infertility-related stress and strengthening coping strategies.
No Intervention: Routine Care; Participants receive routine care provided by the IVF center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infertility-related stress	Infertility-related stress assessed using the COMPI Fertility Problem Stress Scales, a 14-item multidimensional scale measuring personal, marital, and social aspects of infertility-related stress. Total scores range from 0 to 50, with higher scores indicating higher levels of infertility-related stress.	Baseline, after oocyte retrieval, and 1 month after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping strategies	Coping strategies assessed using the COMPI Coping Strategy Scales, a 19-item scale evaluating strategies for managing infertility-related stress, including active, passive, and meaning-based coping. Total scores vary across subscales, with higher scores indicating greater use of coping strategies.	Baseline, after oocyte retrieval, and 1 month after embryo transfer

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Infertility; Assisted Reproductive Technology; In Vitro Fertilization; Randomized Controlled Trial; Supportive Care; Coping; Couples; Infertility-related Stress; Swanson Caring Theory
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: OMU-SWANSON CARE-IVF-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data are not publicly available due to ethical and confidentiality considerations but may be shared upon reasonable request, subject to approval by the relevant ethics committee.

Drug and device information, study documents

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