Reproductive HealthNCT05664048
Effects of Dry Heat Application for Menstrual Symptoms
A study testing Dry heat application in people with Reproductive Health, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was to determine the effect of dry heat applied on foot base of the 65 nursing students on menstrual symptoms and pain. A statistically significant difference was found between the three-day Visual Analog Pain Scale in both intervention and control groups. Read more about this study
- Who is it for?
- Ages 18 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health
- What is being tested?
- Dry heat application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 29 Nov 2019
- 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 22 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- having no diagnosis of psychiatric disorder and history of endometriosis
- stated that they menstruated regularly (between 22-35 days),
- not use complementary and alternative treatments such as analgesics or massage throughout the study,
- having no diabetes or neuropathic problem causing nerve injury,
- not take oral contraceptives,
- were over 18 years,
- agreed to participate in the study
Who cannot join
- analgesics during the study
- not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dry Heat Application on Menstrual Symptoms and Pain: A Randomized Controlled Trial
This randomized controlled trial was to determine the effect of dry heat applied on foot base of the 65 nursing students on menstrual symptoms and pain. A statistically significant difference was found between the three-day Visual Analog Pain Scale in both intervention and control groups. However, there was no difference between Menstruation Symptom Scale subscale and total score avg of the intervention and control groups. Applying hot pack to the sole of the foot can be expressed as an effective method to reduce pain. However, due to premenstrual syndrome is a complex process, the reduction of pain in the later days of the menstrual cycle in both groups can be psychological or be explained for physiological reasons.
Read the detailed description
The study was conducted as a randomized controlled trial, a non-blinded between 30 September 2019 and 29 November 2019. In the first stage of the present study, the Premenstrual Syndrome Scale was used for all participants and the study was continued with the students with premenstrual syndrome symptoms based on the data acquired from the Premenstrual Syndrome Scale. This stage was used only for restricting the sample group, rather than diagnosing or treating the students. In the second stage, the randomization of students included in the sample group was presented according to the CONSORT diagram. The population of the study consisted of 452 female nursing students studying in the faculty of health sciences in a university. The students (n=75) who were absent in the school, took analgesics during the study, and did not agree to participate in the study, were excluded from the study. The students, who had no diagnosis of psychiatric disorder and history of endometriosis, stated that they menstruated regularly (between 22-35 days), did not use complementary and alternative treatments such as analgesics or massage throughout the study, had no diabetes or neuropathic problem causing nerve injury, did not take oral contraceptives, were over 18 years, and agreed to participate in the study, were included in the study.
- Conditions
- Reproductive Health
- Being tested
- Dry heat application
- Keywords
- Menstruation, Hot pack application, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry heat applicationBehavioural
Self- dry heat application on the foot during menstrual period with pain.
| Study group | Role | What they receive |
|---|---|---|
| Dry heat application group | Experimental | The participants were informed that they could use the thermophore whenever they felt pain throughout the menstrual cycle. On the first day of the period, they were asked to complete the "Visual Analog Scale" and "Menstrual Symptom Questionnaire" before using the thermophore; apply heat on their sole whenever they felt pain in the first three days of the menstrual period when pain is more intense; rate level of pain twice a day at 12-hour intervals on a daily basis, using the "Visual Analog Scale"; and complete the "Menstrual Symptom Questionnaire" on the last day of the period. On the other hand, the students in the control group completed only the related forms. The students who were previously trained on heat application were trained once again by the researcher as a reminder and then their written consents were obtained through the informed consent form. Receives: Behavioral: Dry heat application |
| Control group | No intervention | The students in the control group completed only the related forms ("Visual Analog Scale" and "Menstrual Symptom Questionnaire") in the period of the menstruation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain due to menstruation.
Visual Analog Scale was used.Used for measurement and follow up of level of pain this scale is a simple method. In a 10-cm horizontal scale, '0' indicates no pain and '10' indicates worst pain. The students were asked to rate their level of pain during their last period by giving a score between 0 and 10 points.
Measured: 10 days.
Menstrual Symptoms.
Menstrual Symptom Questionnaire was used.
Measured: 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start30 Sep 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Reproductive HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kıvan Çevik Kaya, Assoc.Prof., Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664048
- Sponsor's protocol ID
- 2019-045
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be given if it's necessary and if it is not problem for ethical office.
Publications
Negriff S, Dorn LD, Hillman JB, Huang B. The measurement of menstrual symptoms: factor structure of the menstrual symptom questionnaire in adolescent girls. J Health Psychol. 2009 Oct;14(7):899-908. doi: 10.1177/1359105309340995.
PubMed 19786516Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021 Nov 8;21(1):392. doi: 10.1186/s12905-021-01532-w.
PubMed 34749716Jo J, Lee SH. Heat therapy for primary dysmenorrhea: A systematic review and meta-analysis of its effects on pain relief and quality of life. Sci Rep. 2018 Nov 2;8(1):16252. doi: 10.1038/s41598-018-34303-z.
PubMed 30389956Alsaleem MA. Dysmenorrhea, associated symptoms, and management among students at King Khalid University, Saudi Arabia: An exploratory study. J Family Med Prim Care. 2018 Jul-Aug;7(4):769-774. doi: 10.4103/jfmpc.jfmpc_113_18.
PubMed 30234051
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Heat Application on Menstrual Symptoms and Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05664048
- Acronym / sponsor ID
- 2019-045
- Conditions
- Reproductive Health
- Keywords
- Menstruation, Hot pack application, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 23 Dec 2022 (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.
This randomized controlled trial was to determine the effect of dry heat applied on foot base of the 65 nursing students on menstrual symptoms and pain. A statistically significant difference was found between the three-day Visual Analog Pain Scale in both intervention and control groups. However, there was no difference between Menstruation Symptom Scale subscale and total score avg of the intervention and control groups. Applying hot pack to the sole of the foot can be expressed as an effective method to reduce pain. However, due to premenstrual syndrome is a complex process, the reduction of pain in the later days of the menstrual cycle in both groups can be psychological or be explained for physiological reasons.
Detailed description
The study was conducted as a randomized controlled trial, a non-blinded between 30 September 2019 and 29 November 2019. In the first stage of the present study, the Premenstrual Syndrome Scale was used for all participants and the study was continued with the students with premenstrual syndrome symptoms based on the data acquired from the Premenstrual Syndrome Scale. This stage was used only for restricting the sample group, rather than diagnosing or treating the students. In the second stage, the randomization of students included in the sample group was presented according to the CONSORT diagram. The population of the study consisted of 452 female nursing students studying in the faculty of health sciences in a university. The students (n=75) who were absent in the school, took analgesics during the study, and did not agree to participate in the study, were excluded from the study. The students, who had no diagnosis of psychiatric disorder and history of endometriosis, stated that they menstruated regularly (between 22-35 days), did not use complementary and alternative treatments such as analgesics or massage throughout the study, had no diabetes or neuropathic problem causing nerve injury, did not take oral contraceptives, were over 18 years, and agreed to participate in the study, were included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry heat application group | Experimental | Behavioral: Dry heat applicationThe participants were informed that they could use the thermophore whenever they felt pain throughout the menstrual cycle. On the first day of the period, they were asked to complete the "Visual Analog Scale" and "Menstrual Symptom Questionnaire" before using the thermophore; apply heat on their sole whenever they felt pain in the first three days of the menstrual period when pain is more intense; rate level of pain twice a day at 12-hour intervals on a daily basis, using the "Visual Analog Scale"; and complete the "Menstrual Symptom Questionnaire" on the last day of the period. On the other hand, the students in the control group completed only the related forms. The students who were previously trained on heat application were trained once again by the researcher as a reminder and then their written consents were obtained through the informed consent form. |
| Control group | No intervention | –The students in the control group completed only the related forms ("Visual Analog Scale" and "Menstrual Symptom Questionnaire") in the period of the menstruation. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- having no diagnosis of psychiatric disorder and history of endometriosis
- stated that they menstruated regularly (between 22-35 days),
- not use complementary and alternative treatments such as analgesics or massage throughout the study,
- having no diabetes or neuropathic problem causing nerve injury,
- not take oral contraceptives,
Key exclusion criteria (2 listed)
- analgesics during the study
- not agree to participate in the study
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 |
|---|---|---|
| Dry heat applicationSelf- dry heat application on the foot during menstrual period with pain. | Behavioural | Dry heat application group |
Primary outcome
Pain due to menstruation.
Time frame: 10 days.
Visual Analog Scale was used.Used for measurement and follow up of level of pain this scale is a simple method. In a 10-cm horizontal scale, '0' indicates no pain and '10' indicates worst pain. The students were asked to rate their level of pain during their last period by giving a score between 0 and 10 points.
Menstrual Symptoms.
Time frame: 10 days.
Menstrual Symptom Questionnaire was used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Background: PubMed 19786516Negriff S, Dorn LD, Hillman JB, Huang B. The measurement of menstrual symptoms: factor structure of the menstrual symptom questionnaire in adolescent girls. J Health Psychol. 2009 Oct;14(7):899-908. doi: 10.1177/1359105309340995.
- Results publication: PubMed 34749716Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021 Nov 8;21(1):392. doi: 10.1186/s12905-021-01532-w.
- Results publication: PubMed 30389956Jo J, Lee SH. Heat therapy for primary dysmenorrhea: A systematic review and meta-analysis of its effects on pain relief and quality of life. Sci Rep. 2018 Nov 2;8(1):16252. doi: 10.1038/s41598-018-34303-z.
- Results publication: PubMed 30234051Alsaleem MA. Dysmenorrhea, associated symptoms, and management among students at King Khalid University, Saudi Arabia: An exploratory study. J Family Med Prim Care. 2018 Jul-Aug;7(4):769-774. doi: 10.4103/jfmpc.jfmpc_113_18.
- Individual participant dataSharing planned: No. The data will be given if it's necessary and if it is not problem for ethical office.
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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.
Kıvan Çevik Kaya, Assoc.Prof. principal investigator
Manisa Celal Bayar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry heat application in people with Reproductive Health, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 23 Dec 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain due to menstruation. (time frame: 10 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05664048, which also lists 4 linked publications.
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 23 Dec 2022.