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

NCT ID: NCT05708937

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2022-09-20

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.

Detailed Description

Infertility is a process with social, cultural and psychological interaction as well as physical condition. Infertility is a perceived loss for women, men and families. It requires adapting to a childless lifestyle and developing a coping mechanism with the difficulties encountered (Lee, Choi, Chan , Chan , & Ernest, 2009). Infertility treatments are stressful, physically painful and financially demanding life crises for most couples (Boivin, Griffiths, & Venetis, 2011). It is not enough that the nursing care that women who experience such a complex psychosocial process will receive during the same complex treatment process is only physical care. For this reason, individuals in the diagnosis and treatment process of infertility, especially women, need social support (Blevins, 2011).

Providing psychosocial support to infertile patients is one of the important tasks of nursing care.

There are studies in the literature showing that mindfulness-based care is an effective method for improving psychological health (such as quality of life, stress, marital adjustment) in women in infertility clinics (Fard, Kalantarkousheh, & Faramarzi, 2018) (Lunn & Sherratt, 2013) (Shargh, et al. , 2016) (Hosseini, et al., 2020). A study of the mindfulness-based care intervention found increases in awareness levels, self-compassion, and coping strategies in infertile women during their first IVF treatment. Thus, it was found to improve fertility-related quality of life and pregnancy rates (Li, Long, Liu, He, & Li, 2016).

With this project, a mobile application was developed to provide mindfulness-based psychosocial support to infertile women. The mobile application contains mindfulness-based audio recordings developed specifically for infertility. Participants listened regularly (twice a day) to meditation appropriate to the treatment phase.

Psychosocial assessments (pretest and posttest) were applied to measure the benefit of this practice on participants.

The psychosocial status of women receiving infertility treatment was measured through the scales used, and the effect of mobile application and mindfulness nursing support on the participants was evaluated.

Conditions

Infertility; Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Mindfulness based phone app

Intervention Type: 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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness based phone app

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maltepe University

OTHER

Sponsor Role: lead

Responsible Party

Özen İnam

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maltepe Üniversitesi

Istanbul, Maltepe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40114156 (View on PubMed)

Other Identifiers

E-74555795-050.01.04-52289

Identifier Type: -

Identifier Source: org_study_id