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Active, Not Recruiting

NCT Number: NCT06667440

Cryotherapy in Nulliparous Women with Dysmenorrhea

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaga

Málaga, MALAGA, 29076, Spain

About this study

For the recruitment of participants (whose minimum n will be calculated using the G*Power computer software) an online dissemination campaign will be carried out through social networks, physiotherapists specialised in pelvic floor dysfunctions and gynaecologists will be contacted to inquire about the availability of patients who can participate, and students from both the University of Malaga and the University of Valencia will be contacted through official communication channels.

Nulliparous women with primary dysmenorrhea who meet the following inclusion criteria will be recruited: (1) Menstrually active women between the ages of 18 (to avoid guardian authorizations) and 45 (age of onset of menopause according to the National Institute of Aging ), (2) Menstrual cycles ranging from 24 to 38 days according to OASH , (3) Menstrual periods of 3 to 7 days, and (4) Pain lasting 1 to 3 days. Women with a history of underlying diseases causing secondary dysmenorrhea, women with systemic and/or psychiatric illnesses, and women with a history of use of hormonal medications, oral contraceptive pills, or intrauterine devices will be excluded.

The intervention will consist of applying a cold pack to the hypogastric region, with the participant lying supine, twice daily for the first three days of menstruation. Participants will be required to keep an application calendar where they will note when they have applied the cold pack, and will record the variables of interest for this study before and after its application. Three menstrual cycles will be monitored, where researchers responsible for the research team will periodically contact the participants to ensure adherence to the treatment. Participants randomized to the control group will not undergo intervention during this period.

For the dependent variables; pain intensity assessed by the Visual Analogue Scale, sleep quality assessed by the Pittsburgh Sleep Quality Index and quality of life assessed by the World Health Organization Quality of Life Brief Version questionnaire, a statistical analysis will be performed using the repeated measures ANOVA test to determine the evolution of these variables during the three menstrual cycles. A posteriori, a correlation analysis will be performed between the results of this test and the physical activity levels of the participants, assessed using the International Physical Activity Questionnaire-Short Form , in addition to the socioeconomic status, assessed using the Kuppuswamy Socioeconomic Status Scale .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cryotherapy

Other

Women in the intervention group will apply cryotherapy on their hypogastrium with a coldpack

Primary outcomes

  1. NUMERICAL RATING SCALE (NRS)

    Time frame: From enrollment to the end of the treatment at 6 months

    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.

Secondary outcomes

  1. Pittsburgh Quality Sleep Index (PQSI)

    Time frame: From enrollment to the end of the treatment at 6 months

    Self-report questionnaire that assesses sleep quality and disturbances over the past month. It comprises several components, including sleep duration, sleep disturbances, and overall sleep quality.

    Interpretation: Score Range (0-21): 0 indicates no difficulty and higher total score (21) indicates poorer sleep quality, making it useful for identifying individuals with sleep issues and monitoring changes following interventions.

  2. World Health Organization Quality of Life Brief Version (WHOQOL-BREF)

    Time frame: From enrollment to the end of the treatment at 6 months

    Quality of life assessment tool that evaluates an individual's perception of their position in life across four domains: physical health, psychological health, social relationships, and environment.

    Interpretation: Score Range (4-20): Higher scores in each domain reflect better quality of life, helping to identify areas needing improvement and assess the impact of health interventions.

Other outcomes

  1. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    Time frame: Prior to initiation of treatment

    Questionnaire that measures the level of physical activity in adults over the past week, capturing activities across different intensities (vigorous, moderate, walking).

    Interpretation: Expressed as MET-min per week: . The results help classify individuals as physically active (at least 3000 MET-minutes/week), minimally active (at least 600 MET-min/week), or inactive, informing public health strategies and individual health planning.

  2. Kuppuswamy Socioeconomic Status Scale

    Time frame: Prior to initiation of treatment

    This scale assesses socioeconomic status based on education, occupation, and income. It categorizes individuals into different socioeconomic classes (upper, middle, lower) based on these criteria.

    Interpretation: Score Range (1-29): According to the total score thus calculated, the family is placed in the appropriate socioeconomic class (from 26-29: Upper class to below 5: lower). It provides insights into the social determinants of health and can help correlate socioeconomic factors with health outcomes, aiding in targeted interventions.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

Effectiveness of Cryotherapy in Nulliparous Women with Dysmenorrhea. a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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