Mandala Activity Accompanied With Two Different Music on Infertility

Infertility Clinical Trial

Official title:

Stress Level and the Effect of Mandala Activity Accompanied With Two Different Music on Infertility Women With Embryo Transfer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839171
• Other study ID #: DBEYDAG001*
• Status: Completed
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2023
• Source: Istanbul Gedik University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coping Behavior
• Infertility
• Stress

Intervention

Behavioral:
• music and mandala coloring
Listening to music and coloring mandalas for women who have undergone embryo transfer and are waiting at home

Locations

Country	Name	City	State
Turkey	Kerime Derya BEYDAG	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Gedik University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Curry, N. A., Kasser, T. Can Coloring Mandalas Reduce Anxiety?. Journal Of The American Art Therapy Association,2005, 22(2), 81-85.

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.

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.

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.

Lee, S. Why Color Mandalas? A Study Of Anxiety-Reducing Mechanisms. Journal of the American Art Therapy Association, 2018,35(1), 35-41.

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Yilmaz , 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.	8 month
Primary	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.	8 month