NCT05901181

Brief Summary

In order to evaluate the effects of laughter yoga on the quality of life, stress, cortisol, blood pressure levels and conscious self-care powers of menopausal women, it will be performed in two stages (the first stage is qualitative and the second stage is randomized controlled) on menopausal women in the TRNC Famagusta region.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 22, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

May 22, 2023

Last Update Submit

June 12, 2023

Conditions

Keywords

Laughter YogaMenopauseStressSelf Care

Outcome Measures

Primary Outcomes (3)

  • The Effect of Laughter Yoga on Self-Care in Menopause

    Conscious Awareness Based Self-Care Scale: The Conscious Awareness-Based Self-Care Scale developed by Cook-Cottone and Guyker (2018) is a multidimensional tool that examines self-care through the perceived involvement of individuals in the areas of physical, cognitive, emotional and social care and consists of 33 items. Conscious self-care is measured in six sub-dimensions: physical care, supportive relationships, mindfulness, self-compassion and purpose, conscious relaxation and supportive structure. The internal consistency coefficient was .89 for the general scale and .69, .86, .92, .83, .77, and .77 for the subscales, respectively. The Turkish validity and reliability study of the scale was carried out by Sünbül et al. (2018) and the internal consistency coefficient was .89 for the general scale and .72, .81, .81, .83, .66, and .80 for the subscales, respectively. E-mail permission has been obtained for the use of the scale.

    8 WEEKS

  • The Effect of Laughter Yoga on Stress Level in Menopause

    Perceived Stress Scale: The Perceived Stress Scale (PSS) was developed by Cohen, Kamarck, and Mermelstein in 1983. The scale consists of a total of 14 items and is designed to measure how stressful the individual perceives the situations in his life. Turkish validity and reliability studies of the scale were carried out by Eskin et al. in 2013. The items of the 14-item form preferred in this study are scored between 0-4. Scoring of the scale; Never (0), Almost never (1), Sometimes (2), Quite often (3), and Very often (4). The score of PSS-14 varies between 0-56; A high score means that the perception of stress is high. In scale; Items 4, 5, 6, 7, 9, 10 and 13 are reverse scored. The test-retest reliability coefficient of the scale was 0.87 and the cronbach alpha internal consistency coefficient was 0.84. E-mail permission was obtained for the use of the scale.

    8 WEEKS

  • The Effect of Laughter Yoga on Quality of Life Scale Level in Menopause

    Self-Care Strength Scale (PSAS): The scale used to measure an individual's self-care ability or self-care power was developed in English by Kearney and Fleicher (1979) with 43 items, and an abbreviated 35-item Turkish form was adapted by Nahcivan. The scale focused on individuals' self-assessment of their involvement in self-care actions. Each statement is scored from 0 to 4. In the Turkishized scale, 8 items (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and the scoring is reversed. The maximum score is 140. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual. There is no cut off value. E-mail permission has been obtained for the use of the scale.

    8 WEEKS

Study Arms (2)

Laughter Yoga Group

EXPERIMENTAL

When we look at the literature, the Laughter Yoga practice is held between 2 weeks and 10 weeks, once a week, 5 times a week, 2 weeks and lasting approximately 25-45 minutes. In this study, the intervention will be implemented within 8 weeks. To the women who constitute the intervention group; After giving short-term self-care training in Menopause for 8 weeks, relaxation will be applied after the practice of Laughter yoga, which starts with breathing exercises, warm-up exercises, childlike games and has different exercises in each session. The research will be carried out in the Famagusta Municipality Development Academy, in a bright hall where women can take a U shape, everyone will be face to face, and will not be disturbed during the application.

Behavioral: Laughter Yoga

Control Group

NO INTERVENTION

Routine care was given to the control group

Interventions

Laughter YogaBEHAVIORAL

Laughter yoga is a childlike practice where group members make eye contact with each other. It is a breath yoga practiced by imitating games and fake laughing. Brain the effects of real laughter on the body, as it cannot distinguish between fake and real laughter. showing positive effects. It consists of sessions lasting at least 20 minutes and an average of 45 minutes.

Also known as: control
Laughter Yoga Group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who have been in menopause for the last five years
  • At least 1 year past the last menstrual period
  • Women between the ages of 45-60
  • Willingness to participate in the research
  • No communication barrier (cognitive affective)

You may not qualify if:

  • Not knowing Turkish
  • Having surgical menopause
  • State their willingness to withdraw from the research voluntarily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek Karaoğlan Gülevi

Famagusta, 99450, Cyprus

Location

Related Publications (6)

  • Treloar AE. Menstrual cyclicity and the pre-menopause. Maturitas. 1981 Dec;3(3-4):249-64. doi: 10.1016/0378-5122(81)90032-3.

  • Grindler NM, Santoro NF. Menopause and exercise. Menopause. 2015 Dec;22(12):1351-8. doi: 10.1097/GME.0000000000000536.

  • Sussman M, Trocio J, Best C, Mirkin S, Bushmakin AG, Yood R, Friedman M, Menzin J, Louie M. Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC Womens Health. 2015 Aug 13;15:58. doi: 10.1186/s12905-015-0217-y.

  • Woods NF, Mitchell ES. Symptoms during the perimenopause: prevalence, severity, trajectory, and significance in women's lives. Am J Med. 2005 Dec 19;118 Suppl 12B:14-24. doi: 10.1016/j.amjmed.2005.09.031.

  • Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006.

  • Guerin E, Goldfield G, Prud'homme D. Trajectories of mood and stress and relationships with protective factors during the transition to menopause: results using latent class growth modeling in a Canadian cohort. Arch Womens Ment Health. 2017 Dec;20(6):733-745. doi: 10.1007/s00737-017-0755-4. Epub 2017 Jul 13.

MeSH Terms

Conditions

Laughter

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Central Study Contacts

Dilek Karaoğlan Gülevi, 1

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: study design Applications of women will be received by making announcements of the research and laughter yoga trainings through posters hung in the center of the district to menopausal women in the 45-60 age group in the district. After the applications, menopausal women who meet the research criteria and volunteer to participate in the research will be randomly assigned to the intervention and control groups by drawing lots to determine which group they will be in.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SENIOR INSTRUCTOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 13, 2023

Study Start

June 30, 2023

Primary Completion

February 16, 2024

Study Completion

February 16, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP, ICF, CSR

Locations