Clinical trial NCT05839171: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Stress
Coping Behavior
Lead sponsor: Istanbul Gedik University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The effect of music and mandala activity on stress level
timeFrame: 8 month
measure: The effect of music and mandala activity on level of coping with stress
timeFrame: 8 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kerime Derya BEYDAG
Study officials:
affiliation: https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
name: Kerime Derya BEYDAG
role: STUDY_DIRECTOR
References:
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.
citation: Lee, S. Why Color Mandalas? A Study Of Anxiety-Reducing Mechanisms. Journal of the American Art Therapy Association, 2018,35(1), 35-41.
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.
citation: Maleki, F., Shams, J., & Fallahi Khoshknab, M. (2013). The Effect of Coloring Mandala on Anxiety of Infertile Women. Journal of Caring Sciences, 2(3), 189-195.
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.
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.
citation: Curry, N. A., Kasser, T. Can Coloring Mandalas Reduce Anxiety?. Journal Of The American Art Therapy Association,2005, 22(2), 81-85.