跳至主要内容
临床试验/NCT07557069
NCT07557069已完成不适用

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

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • - 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

研究组 & 干预措施

Swanson-Based Supportive Care

Experimental

Participants receive structured supportive care based on Swanson's Caring Theory, including education and counseling throughout the ART process.

干预措施: Swanson Caring Theory-based supportive care (Behavioral)

Routine Care

No Intervention

Participants receive routine care provided by the IVF center.

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serap TEMİZ

Associate professor

Ondokuz Mayıs University

研究点 (1)

Loading locations...

相似试验