NCT07036913

Brief Summary

Effectiveness of somatocognitive therapy with TENS and stretching exercises on menstrual pain and quality of life with dysmenorrhea.A randomized controlled trial The objective of this study is to find weather which therapy; somatocognitive therapy along with TENS or stretching exercises is more effective and what are their effects on quality of life in females with dysmonarrhea.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Numerical rating scale

    A pain screening tool, commonly use to assess pain severity at that moment in time using a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain".

    6 Month

  • Menstrual distress questionnaire

    The MSQ is a 24-46 item self-report measure which assesses menstrual pain and symptoms .The score on each item ranges from 1 (never) to 5 (always) with a higher composite score indicating more symptoms.

    6 Months

Study Arms (2)

somatocognitive therapy

EXPERIMENTAL
Diagnostic Test: somatocognitive therapy

Stretching exercises

ACTIVE COMPARATOR
Combination Product: Stretching exercises

Interventions

In somatocognitive therapy which includes drawing( three days prior to menustration in first two months and the first day of menustration in third month) and music(in the first 12 hours of menustration)along with TENS(thirty minutes on abdominal region, upon the onset of dysmonarrhea).

somatocognitive therapy
Stretching exercisesCOMBINATION_PRODUCT

Stretching exercises of abdominal, lumbar or pelvic region will be performed as a treatment. Frequency:15 minutes;three times per week.

Stretching exercises

Eligibility Criteria

Age13 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Females who are facing menustral pain during their every menses.
  • Females who are facing dysmonarrhea from the at least last three months.
  • Females who are willing to take part in the research.

You may not qualify if:

  • Females with some hormonal problem.
  • Females with irregular menustral cycle.
  • Females who face menustral pain during some of their menses
  • Pregnant females
  • Females with recent abdominal/pelvic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore City

Lahore, Pakistan

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

March 4, 2025

Primary Completion

June 1, 2025

Study Completion

September 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations