Cryotherapy in Nulliparous Women with Dysmenorrhea
Effectiveness of Cryotherapy in Nulliparous Women with Dysmenorrhea. a Randomized Controlled Trial
1 other identifier
interventional
180
1 country
1
Brief Summary
The aim of this randomized controlled trial is to observe the effectiveness of cryotherapy application in nulliparous women with primary dysmenorrhea regarding pain intensity, sleep quality and quality of life. It is also intended to analyse whether the levels of physical activity and the socioeconomic status of the participants are determining factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
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
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
September 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 4, 2024
September 1, 2024
6 months
September 10, 2024
October 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
NUMERICAL RATING SCALE (NRS)
Subjective measure used to assess the intensity of pain or other symptoms on a scale from 0 to 10, where 0 indicates no pain or symptom and 10 represents the worst possible experience. Interpretation: Higher scores indicate greater severity, allowing clinicians to evaluate changes in symptoms over time or the effectiveness of interventions.
From enrollment to the end of the treatment at 6 months
Secondary Outcomes (2)
Pittsburgh Quality Sleep Index (PQSI)
From enrollment to the end of the treatment at 6 months
World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
From enrollment to the end of the treatment at 6 months
Other Outcomes (2)
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Prior to initiation of treatment
Kuppuswamy Socioeconomic Status Scale
Prior to initiation of treatment
Study Arms (2)
CRIOTHERAPY
EXPERIMENTALWomen in the intervention group will apply cryotherapy on their hypogastrium with a coldpack
CONTROL
NO INTERVENTIONInterventions
Women in the intervention group will apply cryotherapy on their hypogastrium with a coldpack
Eligibility Criteria
You may qualify if:
- Menstrually active women
- Menstrual cycles that vary between 24 and 38 days according to the OASH
- menstrual periods between 3 and 7 days, and
- Pain lasting from 1 to 3 days
You may not qualify if:
- Patients suffering diseases that generate secondary dysmenorrhea, with systemic or psychiatric diseases, and patients with a history of use of hormonal medication, birth control pill, or intrauterine devices
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Malaga
Málaga, MALAGA, 29076, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profesor Titular
Study Record Dates
First Submitted
September 10, 2024
First Posted
October 31, 2024
Study Start
June 1, 2024
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
November 4, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share