NCT06421909

Brief Summary

Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 18, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 15, 2024

Last Update Submit

May 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • menopausal women who participate in the mindfulness-based educational intervention will experience significant reductions in anxiety inventory score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered

    three months

Secondary Outcomes (1)

  • menopausal women who participate in the mindfulness-based educational intervention will experience reductions in stress scale score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered

    three months

Study Arms (2)

mindfulness-based educational intervention group

EXPERIMENTAL
Behavioral: mindfulness-based educational intervention

non-intervention group

NO INTERVENTION

Interventions

Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.

mindfulness-based educational intervention group

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in age of menopause

You may not qualify if:

  • age of menarche
  • older than 70 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Alexandria Governorate, 21913, Egypt

RECRUITING

Related Publications (1)

  • Amin SM, El-Gazar HE, Zoromba MA, El-Sayed MM, Awad AGE, Atta MHR. Mindfulness for Menopausal Women: Enhancing Quality of Life and Psychological Well-Being Through a Randomized Controlled Intervention. J Nurs Scholarsh. 2025 Jul;57(4):563-575. doi: 10.1111/jnu.70003. Epub 2025 Feb 24.

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
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 20, 2024

Study Start

April 18, 2024

Primary Completion

June 30, 2024

Study Completion

August 28, 2024

Last Updated

May 20, 2024

Record last verified: 2024-05

Locations