NCT05839171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

March 30, 2023

Last Update Submit

April 20, 2023

Conditions

InfertilityStressCoping Behavior

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 month

  • 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

Study Arms (3)

Person's Chosen Music + Mandala coloring

EXPERIMENTAL

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

Behavioral: music and mandala coloring

Meditation Music + Mandala coloring

EXPERIMENTAL

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

Behavioral: music and mandala coloring

Standard care

NO INTERVENTION

Every day

Interventions

music and mandala coloringBEHAVIORAL

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

Meditation Music + Mandala coloringPerson's Chosen Music + Mandala coloring

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who have undergone embryo transfer and are in the waiting period
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerime Derya BEYDAG

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

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

    RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Kerime Derya BEYDAG

    https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 3, 2023

Study Start

November 19, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)