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

Primary Purpose

Infertility, Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mindfulness based phone app
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring Infertility, Female Infertility, Mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maltepe Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2022
Last Updated
January 24, 2023
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05708937
Brief Title
THE EFFECT OF COGNITIVE AWARENESS SUPPORT ON THE PSYCHOSOCIAL STATUS OF WOMEN TREATED FOR INFERTILITY
Official Title
Assistant Proffessor Ph.D.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Infertility, Female
Keywords
Infertility, Female Infertility, Mindfulness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group participants used the mindfulness mobile application. Then, the psychosocial status of the participants was measured with scales.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group participants did not receive any intervention. Classical care was applied. Then, the psychosocial status of the participants was measured with scales.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based phone app
Intervention Description
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
Primary Outcome Measure Information:
Title
Personal Information Form
Description
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.
Time Frame
6 weeks
Title
Cognitive Awareness Scale
Description
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
Time Frame
1 year
Title
Infertility Self-Efficacy Scale
Description
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.
Time Frame
1 year
Title
Depression Anxiety Stress Short Scale (DASS 21)
Description
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.
Time Frame
1 year
Title
Mobile Application Evaluation Results
Description
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.
Time Frame
1 year
Title
Fertility Adjustment Scale
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Maltepe Üniversitesi
City
Istanbul
State/Province
Maltepe
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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