Clinical trial NCT05708937: THE EFFECT OF COGNITIVE AWARENESS SUPPORT ON THE PSYCHOSOCIAL STATUS OF WOMEN TREATED FOR INFERTILITY
Official title: Assistant Proffessor Ph.D.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Infertility, Female
Keywords: Infertility
Female Infertility
Mindfulness
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Personal Information Form
timeFrame: 6 weeks
measure: Cognitive Awareness Scale
timeFrame: 1 year
measure: Infertility Self-Efficacy Scale
timeFrame: 1 year
measure: Depression Anxiety Stress Short Scale (DASS 21)
timeFrame: 1 year
measure: Mobile Application Evaluation Results
timeFrame: 1 year
measure: Fertility Adjustment Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe Üniversitesi
state: Maltepe
Study officials:
References: