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Mandala Activity Accompanied With Two Different Music on Infertility

Primary Purpose

Infertility, Stress, Coping Behavior

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music and mandala coloring
Sponsored by
Istanbul Gedik University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Being primary infertile, Embryo transfer (ET) has been made, Beta Hcg value measurement is in the waiting phase, Not receiving psychological counseling from a specialist (psychologist, psychiatrist), Mandala activity, yoga, meditation, acupuncture, etc. to relieve stress. not applying a method, Not having difficulties in communicating Agree to participate in the research. Exclusion Criteria: Being secondary infertile. Bleeding, miscarriage, etc. after embryo transfer. to have lived, Having difficulties in communicating, Applying alternative methods such as mandala activity, yoga, meditation, acupuncture, etc., Receiving psychological counseling from a specialist (psychologist, psychiatrist), Not wanting to participate in the research.

Sites / Locations

  • Kerime Derya BEYDAG

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Person's Chosen Music + Mandala coloring

Meditation Music + Mandala coloring

Standard care

Arm Description

Every day for at least 20 minutes/7-10 days

Every day for at least 20 minutes/7-10 days

Every day

Outcomes

Primary Outcome Measures

The effect of music and mandala activity on stress level
The COMPI Fertility Problem Stress Scales), The COMPI Fertility Problem Stress Scale, which was validated and reliable in Turkish by Yılmaz , is a 14-item scale that consists of three sub-dimensions and can be applied to both women and men.One of the aims of the study is to reduce the stress level of painting mandala accompanied by music. For this reason, the COMPI scale was filled before the application was made in the first interview with the patients. The patients painted mandala for at least 20 minutes, accompanied by music, every day for 10 days. At the end of the 10th day, the COMPI scale was filled again before the betahcg value was checked.
The effect of music and mandala activity on level of coping with stress
One of the aims of the study is to reduce the stress level of painting mandala accompanied by music. For this reason, the The COMPI Coping Strategy Scales was filled before the application was made in the first interview with the patients. The patients painted mandala for at least 20 minutes, accompanied by music, every day for 10 days. At the end of the 10th day, the The COMPI Coping Strategy Scales was filled again before the betahcg value was checked.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2023
Last Updated
April 20, 2023
Sponsor
Istanbul Gedik University
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1. Study Identification

Unique Protocol Identification Number
NCT05839171
Brief Title
Mandala Activity Accompanied With Two Different Music on Infertility
Official Title
Stress Level and the Effect of Mandala Activity Accompanied With Two Different Music on Infertility Women With Embryo Transfer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Gedik 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
In this study; In this study, it is aimed to determine the stress level and the effect of the mandala activity, which is applied to two different musical accompaniments, on coping with stress in infertile women who have undergone embryo transfer.The research was carried out as a randomized controlled experimental study with women who had embryo transfer at Private Samsun Medicana International Hospital IVF Center and Private Samsun VM Medical Park Hospital IVF Center between 01.07.2021 and 31.07.2022. Introductory Information Form, Infertility Stress Scale (PSS), and Infertility Stress Coping Scale (PSSS) were applied to intervention groups with embryo transfer. The intervention group started right after the embryo transfer and performed a mandala activity accompanied by music or meditation music of their own choosing until the day before the BetaHcg test, and the ISS and PSS were repeated one day before the BetaHcg test. Both groups were provided with the application for at least 7-10 days. After embryo transfer to the control group, Introductory Information Form, PSS and PSS were applied, and PSS and PSS were repeated one day before the BetaHCG test, and no intervention was made other than routine practices.
Detailed Description
In this study; In this study, it is aimed to determine the stress level and the effect of the mandala activity, which is applied to two different musical accompaniments, on coping with stress in infertile women who have undergone embryo transfer. The research was carried out as a randomized controlled experimental study with women who had embryo transfer at Private Samsun Medicana International Hospital IVF Center and Private Samsun VM Medical Park Hospital IVF Center between 01.07.2021 and 31.07.2022. Introductory Information Form, Infertility Stress Scale (PSS), and Infertility Stress Coping Scale (PSSS) were applied to intervention groups with embryo transfer. The intervention group started right after the embryo transfer and performed a mandala activity accompanied by music or meditation music of their own choosing until the day before the BetaHcg test, and the ISS and PSS were repeated one day before the BetaHcg test. Both groups were provided with the application for at least 7-10 days. After embryo transfer to the control group, Introductory Information Form, PSS and PSS were applied, and PSS and PSS were repeated one day before the BetaHCG test, and no intervention was made other than routine practices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Stress, Coping Behavior

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Person's Chosen Music + Mandala coloring
Arm Type
Experimental
Arm Description
Every day for at least 20 minutes/7-10 days
Arm Title
Meditation Music + Mandala coloring
Arm Type
Experimental
Arm Description
Every day for at least 20 minutes/7-10 days
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Every day
Intervention Type
Behavioral
Intervention Name(s)
music and mandala coloring
Intervention Description
Listening to music and coloring mandalas for women who have undergone embryo transfer and are waiting at home
Primary Outcome Measure Information:
Title
The effect of music and mandala activity on stress level
Description
The COMPI Fertility Problem Stress Scales), The COMPI Fertility Problem Stress Scale, which was validated and reliable in Turkish by Yılmaz , is a 14-item scale that consists of three sub-dimensions and can be applied to both women and men.One of the aims of the study is to reduce the stress level of painting mandala accompanied by music. For this reason, the COMPI scale was filled before the application was made in the first interview with the patients. The patients painted mandala for at least 20 minutes, accompanied by music, every day for 10 days. At the end of the 10th day, the COMPI scale was filled again before the betahcg value was checked.
Time Frame
8 month
Title
The effect of music and mandala activity on level of coping with stress
Description
One of the aims of the study is to reduce the stress level of painting mandala accompanied by music. For this reason, the The COMPI Coping Strategy Scales was filled before the application was made in the first interview with the patients. The patients painted mandala for at least 20 minutes, accompanied by music, every day for 10 days. At the end of the 10th day, the The COMPI Coping Strategy Scales was filled again before the betahcg value was checked.
Time Frame
8 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women who have undergone embryo transfer and are in the waiting period
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being primary infertile, Embryo transfer (ET) has been made, Beta Hcg value measurement is in the waiting phase, Not receiving psychological counseling from a specialist (psychologist, psychiatrist), Mandala activity, yoga, meditation, acupuncture, etc. to relieve stress. not applying a method, Not having difficulties in communicating Agree to participate in the research. Exclusion Criteria: Being secondary infertile. Bleeding, miscarriage, etc. after embryo transfer. to have lived, Having difficulties in communicating, Applying alternative methods such as mandala activity, yoga, meditation, acupuncture, etc., Receiving psychological counseling from a specialist (psychologist, psychiatrist), Not wanting to participate in the research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerime Derya BEYDAG
Organizational Affiliation
https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
Official's Role
Study Director
Facility Information:
Facility Name
Kerime Derya BEYDAG
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Van der Vennet, R., & Serice, S. Can Coloring Mandalas Reduce Anxiety? A replication study. Journal of the American Art Therapy Association, 2012,29(2), 87-92.
Results Reference
background
Citation
Lee, S. Why Color Mandalas? A Study Of Anxiety-Reducing Mechanisms. Journal of the American Art Therapy Association, 2018,35(1), 35-41.
Results Reference
background
Citation
Kim, J., & Kim, S. (2018).The Effect Of Coloring Mandala On Stress and Relaxation In Women Undergoing In Vitro Fertilization Treatment. Journal Of Korean Academy Of Nursing,48(5), 647-655.
Results Reference
background
PubMed Identifier
25276726
Citation
Yektatalab S, Sharif F, Kaveh MH, Fallahi Khoshknab M, Petramfar P. Living with and caring for patients with Alzheimer's disease in nursing homes. J Caring Sci. 2013 Aug 27;2(3):187-95. doi: 10.5681/jcs.2013.023. eCollection 2013 Sep.
Results Reference
background
Citation
Ghasemi, M., Dehghani, M., & Tahmasebi, R. (2015). The Effect Of Coloring Mandala On Anxiety And Stress In Infertile Women. International Journal Of Community Based Nursing And Midwifery, 3(3), 214-221.
Results Reference
background
Citation
Jafari, Z., & Zarei, E. (2017). The Effect Of Mandala Coloring On The Stress And Anxiety Of Infertile Women. Journal Of Caring Sciences, 6(2), 141-148.
Results Reference
background
Citation
Curry, N. A., Kasser, T. Can Coloring Mandalas Reduce Anxiety?. Journal Of The American Art Therapy Association,2005, 22(2), 81-85.
Results Reference
result

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Mandala Activity Accompanied With Two Different Music on Infertility

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