DysmenorrheaNCT06667440
Cryotherapy in Nulliparous Women with Dysmenorrhea
A study testing Cryotherapy in people with Dysmenorrhea, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Cryotherapy in Nulliparous Women with Dysmenorrhea. a Randomized Controlled Trial
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.
Read the detailed description
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 .
- Conditions
- Dysmenorrhea
- Being tested
- Cryotherapy
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Women in the intervention group will apply cryotherapy on their hypogastrium with a coldpack
| Study group | Role | What they receive |
|---|---|---|
| CRIOTHERAPY | Experimental | Women in the intervention group will apply cryotherapy on their hypogastrium with a coldpack Receives: Other: Cryotherapy |
| CONTROL | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the treatment at 6 months
Secondary outcomes (2)
Pittsburgh Quality Sleep Index (PQSI)
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.
Measured: From enrollment to the end of the treatment at 6 months
World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
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.
Measured: From enrollment to the end of the treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESTHER DIAZ-MOHEDO, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667440
- Sponsor's protocol ID
- CEUMA: 87-2024-H
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cryotherapy in Nulliparous Women with Dysmenorrhea. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06667440
- Acronym / sponsor ID
- CEUMA: 87-2024-H
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRIOTHERAPY | Experimental | Other: CryotherapyWomen in the intervention group will apply cryotherapy on their hypogastrium with a coldpack |
| CONTROL | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyWomen in the intervention group will apply cryotherapy on their hypogastrium with a coldpack | Other | CRIOTHERAPY |
Primary outcome
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.
2 secondary outcomes
Pittsburgh Quality Sleep Index (PQSI)
Time frame: From enrollment to the end of the treatment at 6 months
World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Time frame: From enrollment to the end of the treatment at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Dysmenorrhea, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NUMERICAL RATING SCALE (NRS) (time frame: From enrollment to the end of the treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.