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DYSMENORRHEANCT04572555

Heat Application on Depression, Anxiety, Menstrual Attitude and Dysmenorrhea

A study testing Heat Treatment in people with DYSMENORRHEA, run by Balikesir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

AIM: Establishing the effects of heat application on depression, anxiety, menstrual attitude and severity of dysmenorrhea. METHODS: This randomized controlled prospective experimental trial was conducted with 43 students who were suffering from dysmenorrhea under 2 groups, the heat treatment group (n=20) and the… Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
DYSMENORRHEA
What is being tested?
Heat Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2019to 30 Jun 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 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • the ages of 18-30,
  • being nulliparous,
  • having a VAS score of 2 and higher,
  • not having a systemic or chronic disease
  • not using hormonal contraceptives.

Who cannot join

  • using forms of analgesic and alternative treatments during the study
  • experiencing menstrual irregularities

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hülya TÜRKMEN

    Balıkesir, 10100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Heat Application on Depression, Anxiety, Menstrual Attitude and Severity of Dysmenorrhea at 4 Menstrual Cycle

AIM: Establishing the effects of heat application on depression, anxiety, menstrual attitude and severity of dysmenorrhea.

METHODS: This randomized controlled prospective experimental trial was conducted with 43 students who were suffering from dysmenorrhea under 2 groups, the heat treatment group (n=20) and the control group (n=23). To the heat treatment group, dry heat was applied for 20 minutes to the lower abdominal region of the subjects when their dysmenorrhea was most severe. The control group did not receive any treatments. The data were acquired by using a Personal Information Form. The Visual Analogue Scale (VAS) for determining the severity of dysmenorrhea, the Short Form McGill Pain Questionnaire to establish the type of pain, the Menstrual Attitude Questionnaire to establish the attitude and the practices during dysmenorrhea and the Depression Anxiety and Stress Scale to determine the psychological impacts of dysmenorrhea were used. In the first menstrual cycle, both groups received the questionnaires, and no treatment was applied. At the second, third and fourth menstrual cycles, VAS and the McGill Pain Questionnaire were applied before the treatment (T1), right after the treatment (T2) and 2 hours after the treatment (T3). The Menstrual Attitude Questionnaire and the Depression Anxiety and Stress Scale were applied right after the treatment.

Read the detailed description

This experimental randomized controlled prospective study was conducted at the tocology department of a university hospital in Balikesir, Turkey between March 2019 and June 2019.

The sample size was determined using G * Power 3 calculations in accordance with prior studies on heat application to the lower abdomen. Estimation of the effects was acquired from the findings of Potur and Kömürcü (2014), who reported a pain severity of 1.99 ± 2.42 in the heat-treated group and 5.78 ± 2.63 in the control group. We aimed to establish a similar difference. For each group, the sample count was determined as 12. However, in order to increase the power of the study, 23 students were included both in the heat treatment group and the control group, totaling up to 46 individuals for the sample. Power analysis indicated that the size of the sample had a power of 96% with α = 0.05. The decrease comparative to the control group in the severity of dysmenorrhea pain after heat application had an effect size of 0.616.

The inclusion criteria were determined as being at the ages of 18-30, being nulliparous, having a VAS score of 2 and higher [24], not having a systemic or chronic disease and not using hormonal contraceptives. The exclusion criteria were determined as using forms of analgesic and alternative treatments during the study (1 subject in the heat treatment group was excluded at the 3rd menstrual cycle) and experiencing menstrual irregularities (3 subjects in the heat treatment group and 4 subjects in the control group were excluded at the 3rd menstrual cycle).

To the sample of the study, students with dysmenorrhea pain were admitted. Randomization was achieved by having the subjects pull envelopes for the designation of their groups. Students who pulled the 'Heat Treatment Group' were allocated to the heat treatment group, and the students who pulled the 'Control Group' were allocated to the control group. A total of 46 students partook in the study, and 3 students from the heat treatment group were excluded from the study by their own requests. At the 1st and the 2nd menstrual cycles, the heat treatment group consisted of 20 subjects, and the control group consisted of 23. At the 3rd menstrual cycle, 4 subjects from the heat treatment group and 4 subjects from the control group were excluded from the study in accounts of their analgesic medicine usage or inability to menstruate. At the 3rd and 4th menstrual cycles, the heat treatment group had 16 subjects, and the control group had 19.

For the collection of the data, Personal Information Forms were developed by the researchers in accordance with the scientific literature, the Visual Analogue Scale (VAS) in order to establish the severity of the dysmenorrhea pain, the Short Form McGill Pain Questionnaire to determine the types of pain, the Menstrual Attitude Questionnaire to establish the attitudes and the behaviors during menstruation and the Depression Anxiety and Stress Scale to determine the psychological effects of dysmenorrhea were utilized. The Personal Information Form was applied to the heat treatment group and the control group after receiving permission from the subjects. The subjects were observed for a total of 4 menstrual cycles. The subjects in the heat treatment group and the control group were instructed not to use any analgesic medication or alternative treatments during the study. In the 1st menstrual cycle, heat treatment was not applied to the subjects. In the first menstrual cycle, the Short Form McGill Pain Questionnaire, VAS, the Menstrual Attitude Questionnaire and the Depression Anxiety and Stress Scale was applied at the peak severity of dysmenorrhea pain. In the following 3 menstruation cycles, VAS-T1 and the Short Form McGill Pain Questionnaire-T1 were applied to the heat treatment group and the control group at the peak severity of dysmenorrhea pain. Later, 20 minutes of heat treatment was applied to the heat treatment group. The control group were not given any treatments. VAS-T2, the Short Form McGill Pain Questionnaire-T2, the Menstrual Attitude Questionnaire and the Depression Anxiety and Stress scale were applied to the subjects in both groups 20 minutes after the primary evaluation. VAS-T3 and the Short Form McGill Pain Questionnaire were applied to both groups 2 hours after the primary evaluation.

Thermoforming was applied to the lower abdomen by the subjects themselves when the dysmenorrhea pain was at its peak. The subjects were instructed on the application of the thermophores. Thermoforming was applied wrapped in towels in order to shield the subjects from the effects of direct heat. In a study, heat packs that had a temperature of 38.9 °C were used for treatment of dysmenorrhea. In this study, the temperature of the water used in the thermoforming process was 45 °C. Considering the risk of the thermophores cooling down and the shielding provided by the towels, the water temperature was kept higher compared to those in other studies. The temperature of the water was measured using a liquid thermometer. Heat treatment was applied for 20 minutes without interruptions.

Visual Analogue Scale (VAS): This scale was utilized to establish the severity of the dysmenorrhea pain in the subjects. The scale consists of a 10 cm vertical line starting with 0 and ending with 10. In this study, VAS was applied in 4 menstrual cycles; 1st menstrual cycle, once when the pain was most severe (T1), at the 2nd, 3rd and the 4th menstrual cycles, once when the pain was most severe (T1), 20 minutes after the primary application (T2) and 2 hours after the first application (T3).

Short Form McGill Pain Questionnaire (SF-MPQ): This questionnaire was used to establish the type of the dysmenorrhea pain in the subjects. The questionnaire consists of 15 items in 2 sub-scales that consist of the sensory (11 items) and affective pain (4 items) sub-scales. Each item is evaluated with a Likert-type scale between 0 and 3 (0: none, 3: severe), and the sum of these results established the total pain score. Furthermore, the evaluative total pain intensity index was measured using a 6-point Likert-type scale. In this scale '0' represents no detectable pain, whereas '5' represents unbearable pain. The Turkish version of the questionnaire was tested for its validity and reliability in 2007 and found to be reliable and valid.

The Depression Anxiety and Stress Scale (DASS): This scale was developed by Lovibond and Lovibond in 1995 to identify the emotional states of depression, anxiety and stress. The validity and reliability studies of its Turkish form were performed by Akın and Çetin in 2007. The scale includes 42 questions in which the given answers are evaluated quantitively between 0 (not suitable for me) and 3 (fully suitable for me). Depression, anxiety and stress are rated as normal, mild, moderate, advanced and extreme. This scale was included in the study to determine the effects of the heat treatment on depression, anxiety or stress.

Menstrual Attitude Questionnaire (MAQ): The reliability and the validity of the scale used to establish the attitudes and the behaviors of the subjects during menstruation were tested by Kulakaç et al. (2008). The scale includes 31 items as follows; menstruation as a debilitating event (7 items), menstruation as a bothersome event (5 items), menstruation as a natural event (5 items), anticipation and prediction of the onset of menstruation (8 items) and denial of the effects of menstruation (6 items). Each item is evaluated between 1 and 5 (1: I strongly disagree, 5: I strongly agree) using a 5-point Likert-type scoring.

Conditions
DYSMENORRHEA
Being tested
Heat Treatment
Keywords
Dysmenorrhea, Heat Treatment, Depression Anxiety, Stress, Menstrual Attitude
Medical subject headings
Dysmenorrhea, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heat TreatmentOther

    Thermoforming was applied to the lower abdomen by the subjects themselves when the dysmenorrhea pain was at its peak.

Study groups in NCT04572555
Study groupRoleWhat they receive
Heat Treatment GroupExperimentalThermoforming was applied to the lower abdomen by the subjects themselves when the dysmenorrhea pain was at its peak. The subjects were instructed on the application of the thermophores. Thermoforming was applied wrapped in towels in order to shield the subjects from the effects of direct heat. In a study, heat packs that had a temperature of 38.9 °C were used for treatment of dysmenorrhea. In this study, the temperature of the water used in the thermoforming process was 45 °C. Considering the risk of the thermophores cooling down and the shielding provided by the towels, the water temperature was kept higher compared to those in other studies. The temperature of the water was measured using a liquid thermometer. Heat treatment was applied for 20 minutes without interruptions.
Receives: Other: Heat Treatment
Control GroupNo interventionNo Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. severity of dysmenorrhea assessed by Visual Analogue Scale

    Dysmenorrhea level, Visual Analog Scale The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end

    Measured: Change from Baseline severity of dysmenorrhea at 4 months

Secondary outcomes (2)
  1. Rate of Depression, Anxiety and Stress at Menstrual Cycle

    Depression Anxiety and Stress: The scale includes 42 questions in which the given answers are evaluated quantitively between 0 (not suitable for me) and 3 (fully suitable for me). Depression, anxiety and stress are rated as normal, mild, moderate, advanced and extreme. Higher scores mean a more severe depression, anxiety and stress

    Measured: İmmediately after the intervention at 4 Menstrual Cycle

  2. Rate of Menstrual Attitudes at Menstrual Cycle

    Menstrual Attitudes: The scale includes 31 items as follows; menstruation as a debilitating event (7 items), menstruation as a bothersome event (5 items), menstruation as a natural event (5 items), anticipation and prediction of the onset of menstruation (8 items) and denial of the effects of menstruation (6 items). Each item is evaluated between 1 and 5 (1: I strongly disagree, 5: I strongly agree) using a 5-point Likert-type scoring. higher scores mean a better Menstrual Attitudes

    Measured: İmmediately after the intervention at 4 Menstrual Cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2020
  2. Study start1 Mar 2019
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04572555
Sponsor's protocol ID
BalıkesirM
Status last verified
Sep 2020
First submitted
23 Sep 2020
Last updated
1 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Heat Treatment in people with DYSMENORRHEA, run by Balikesir 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 5 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 1 Oct 2020. 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?

severity of dysmenorrhea assessed by Visual Analogue Scale (time frame: Change from Baseline severity of dysmenorrhea at 4 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 1 Oct 2020.

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