THE EFFECT OF COGNITIVE AWARENESS SUPPORT ON THE PSYCHOSOCIAL STATUS OF WOMEN TREATED FOR INFERTILITY

NCT05708937 | Completed

• 1 other identifier: E-74555795-050.01.04-52289
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: With the project, mobile application supported cognitive awareness applications in women receiving infertility treatment; The aim of this study was to measure the effect of infertile women on their psychosocial status. Method: It was planned as a randomized controlled study. It was aimed to reduce stress and increase awareness by applying mindfulness/cognitive awareness to women undergoing infertility treatment. For this reason, special mindfulness suggestions were created for infertile women by taking the opinion of an expert in the field. Mindfulness suggestions created specifically for women with infertility were recorded. The recordings were varied according to the treatment stages, with an average duration of 40 minutes. These audio recordings were presented with a mobile application developed for infertile women. The mobile application called IVFMind was designed for infertile women. The application consists of mindfulness audio recordings and reading sections. The experimental group (n:17) installed this application on their phones and listened to the audio recordings regularly. Cognitive awareness (BIFO), depression-anxiety (DASS 21), infertility self-efficacy and fertility adjustment scales were administered to the experimental and control groups (N:34). Scales were done as pre-test and post-test. The mobile application evaluation form was filled in the experimental group.

Conditions

Infertility; Infertility, Female

Keywords

Infertility; Female Infertility; Mindfulness

Outcome Measures

Primary Outcomes (6)

• Personal Information Form

  This form, prepared by the researcher, consists of 21 items. It questions socio-demographic information such as age, educational status, occupation, duration of marriage, and infertility history, obstetric history and chronic disease status.

  6 weeks

• Cognitive Awareness Scale

  Developed by Brown and Ryan in 2003, the scale aims to measure awareness and attention to momentary experiences in daily life. It gives the total score with its single factor structure, as the score increases, the level of conscious awareness increases. Factor loads range from 27 to 78. It is answered on a 15-item 6-point Likert-type scale (from "almost always" to "almost never"). It aims to determine how often they experience their experiences automatically, without paying attention to the present moment. As the scores obtained from the scale increase; It is understood that cognitive awareness is high. The internal consistency coefficient of the scale is 82

  1 year

• Infertility Self-Efficacy Scale

  The original titled Infertility Self-Efficacy Scale was found in 2006 by Cousineau et al. It was developed to evaluate the self-efficacy perceptions of individuals related to infertility about their emotional, cognitive and behavioral skills. The nine-point Likert-type scale (1- not at all important and 9- very important) consists of a total of 16 items. In 2006, a 10-item short form was created. All statements in the scale are positive. Scores ranging from 10 to 90 are taken from the short form of the scale. The higher the score, the higher the perception of self-efficacy. In the original of the scale, the reliability coefficient was determined as α:94. The scale is unidimensional and scores are between 8 and 32. The higher the score, the higher the perception of self-efficacy.

  1 year

• Depression Anxiety Stress Short Scale (DASS 21)

  Depression anxiety stress short scale (DASS 21) consists of 21 items aiming to measure the level of "depression, anxiety and stress" under three headings. In the normal sample, the test-retest correlation coefficients were found to be r=0.68 for the depression subscale, r=0.66 for the anxiety subscale, and r=0.61 for the stress subscale. This scale is a 4-point Likert-type scale and measures "depression, stress and anxiety dimensions". If the individual scores 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress, it indicates that he or she has a related problem.

  1 year

• Mobile Application Evaluation Results

  It was prepared by the researcher and aims to evaluate users' satisfaction with the mobile application. The usability of the mobile application is aimed at getting the opinions of the patients about the topics to be suggested for the mobile application. The first 4 items of the 6-item form have a 3-point Likert feature (1-yes, 2-no, 3-I'm not sure), while the other 2 items ask open-ended questions about the topics that users want to suggest.

  1 year

• Fertility Adjustment Scale

  The scale, originally named Fertility Adjustment, was developed by Glover et al in 1999 to standardize the measurement of psychological adjustment in infertility. Infertility compliance; It is considered as a concept that includes behavioral, cognitive and emotional aspects. The infertility adjustment scale can be used as a useful tool to evaluate the effect of the treatment process on the psychosocial adjustment of individuals and their psychological needs. The scale is a six-point Likert-type, 12-item scale. The minimum scale score is 12 and the maximum score is 72. The items were balanced in order not to affect the answers in terms of positive and negative statements. Positive items are reverse scored. A high infertility compliance scale score indicates inadequate compliance. In the original of the scale, the reliability coefficient was determined as α.85.

  1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group participants used the mindfulness mobile application. Then, the psychosocial status of the participants was measured with scales.

Behavioral: Mindfulness based phone app

Control group

NO INTERVENTION

The control group participants did not receive any intervention. Classical care was applied. Then, the psychosocial status of the participants was measured with scales.

Interventions

Mindfulness based phone app BEHAVIORAL

Creating mindfulness-based suggestions for infertile women: Mindfulness-based content was created by taking the opinions of experts in the fields of women's health nursing, psychology and linguistics. It consists of 6 different parts. The content of meditation that the patient will apply according to the treatment stage is different. Infertility mindfulness departments; "Breath Awareness, Body \& Uterus Awareness, Needle Therapy and Ovarian Awareness, Pre-Egg Collection (OPU) Diaphragm Breathing, Pre-embryo Transfer Uterine Awareness, Embryo and Uterine Awareness (Post transfer)". Audio recordings of mindfulness-themed meditation content: After the meditation contents are planned; the sound recording was taken with a professional recorder (Sony ICD-PX470). The audio recordings taken were professionally edited by the expert. Mp3 recordings were created by adding background music to sound recordings in computer environment. Audio recordings of mindfulness-themed meditation content

Experimental group

Eligibility Criteria

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

You may qualify if:

• Having completed the Informed consent form and volunteering to participate in the study
• Not having a psychiatric diagnosis (schizophrenia, bipolar disorder, major depression, anxiety disorders, etc.)
• Beginning or soon to start IVF treatment (starting ovarian stimulation)
• Having a maximum of three previous IVF attempts
• Using a smartphone
• Speaks and understands Turkish
• Being over 18 years old

You may not qualify if:

• Termination of treatment at any stage
• Failure to transfer embryos
• Leaving work voluntarily

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe Üniversitesi

Istanbul, Maltepe, Turkey (Türkiye)

Location

Related Publications (1)

• Inam O, Satilmis IG. The effect of mindfulness-based nursing support on the psychosocial status of women receiving infertility treatment: a randomized controlled trial. BMC Womens Health. 2025 Mar 20;25(1):127. doi: 10.1186/s12905-025-03659-6.

  PMID: 40114156 DERIVED

MeSH Terms

Conditions

Infertility; Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: February 1, 2023
• Study Start: May 21, 2021
• Primary Completion: December 16, 2021
• Study Completion: September 20, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)