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

NCT07557069 | Completed

• 1 other identifier: OMU-SWANSON CARE-IVF-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Keywords

Infertility; Assisted Reproductive Technology; In Vitro Fertilization; Infertility-related Stress; Coping; Supportive Care; Swanson Caring Theory; Couples; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Coping strategies

  Baseline, after oocyte retrieval, and 1 month after embryo transfer

Study Arms (2)

Swanson-Based Supportive Care

EXPERIMENTAL

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

Routine Care

NO INTERVENTION

Participants receive routine care provided by the IVF center.

Interventions

Swanson Caring Theory-based supportive care BEHAVIORAL

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.

Swanson-Based Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Health Practice and Research Center

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not informed about the study hypotheses and were asked not to share information about the intervention. Outcome assessment was conducted using standardized questionnaires administered at the same time points in both groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Participants were randomly assigned in a parallel-group design to either an intervention group receiving structured supportive care based on Swanson's Caring Theory or a control group receiving routine care. Outcomes were measured at baseline, after oocyte retrieval, and one month after embryo transfer.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: July 5, 2022
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

TU (1)