NCT04731402

Brief Summary

The aim of the study is to determine the effect of acupressure, laughter yoga and Mindfulness stress reduction program on menopausal symptoms and quality of life.Menopausal period, which is one of the life stages, causes physiological changes and can decrease the quality of life. The research is a randomized controlled trial. 180 women who meet the conditions for research will be included in the study. Three instruments were used to obtain the research data: Personal Information Form,Menopausal Symptoms Rating Scale and Menopause-Specific Quality of Life Scale.

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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

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

January 12, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 12, 2021

Last Update Submit

January 28, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopause symptoms

    Menopause Rating Scale is an 11 item scale.The five-point Likert type scale has three sub-dimensions.The higher the scores of each item, the higher the complaints, the higher the total score of the scale, the higher the menopausal complaints.

    Up to 12 weeks

  • Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopausal quality of life

    Menopausal Quality of Life Scale is a Likert-type scale with 29 questions and consists of four domains: vasomotor, psychosocial, physical and sexual. Each question score is from 0 to 6. The increase in the scale score indicates that the severity of the complaints increased.

    Up to 12 weeks

Study Arms (4)

Acupressure

EXPERIMENTAL

Acupressure group Acupressure application will be applied twice a week, 24 times in total in 12 weeks. Each acupressure point will be massaged for 30 seconds to provide circulation before compression. After the massage, pressures will be applied consecutively for 90 seconds. The session duration for each woman will be 8 minutes in total, with 2 minutes for each point in each attempt.

Other: Acupressure, laughter yoga and mindfulness stress reduction program

Laughter Yoga

EXPERIMENTAL

Laughter Yoga group Laughter yoga sessions begin with gentle warm-up techniques that include stretching and stretching movements, songs, applause, and body movements. Therapy sessions are between 30-45 minutes.8 sessions of laughter yoga will be done once a week.

Other: Acupressure, laughter yoga and mindfulness stress reduction program

mindfulness stress reduction program

EXPERIMENTAL

mindfulness stress reduction program mindfulness stress reduction program consists of 8 weeks. each week is 2.5 hours. each week has a different theme. There is a 6-hour silence day in the 6th week of the program.

Other: Acupressure, laughter yoga and mindfulness stress reduction program

Control Group

NO INTERVENTION

INTERVENTION NOT IMPLEMENTED

Interventions

Initiatives will be applied to the experimental group. only measurement tools will be applied to the control group

AcupressureLaughter Yogamindfulness stress reduction program

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt is a specific study for menopause
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in the menopausal period

You may not qualify if:

  • presence of psychiatric illness using psychiatric medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacer

Malatya, Battalgazi, 44100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

AcupressureLaughter Therapy

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMind-Body Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd

Study Record Dates

First Submitted

January 12, 2021

First Posted

February 1, 2021

Study Start

February 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations