Heat Application on Depression, Anxiety, Menstrual Attitude and Dysmenorrhea

NCT04572555 | Completed

• 1 other identifier: BalıkesirM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

DYSMENORRHEA

Keywords

Dysmenorrhea; Heat Treatment; Depression Anxiety, Stress; Menstrual Attitude

Outcome Measures

Primary Outcomes (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

  Change from Baseline severity of dysmenorrhea at 4 months

Secondary Outcomes (2)

• Rate of Depression, Anxiety and Stress at Menstrual Cycle

  İmmediately after the intervention at 4 Menstrual Cycle

• Rate of Menstrual Attitudes at Menstrual Cycle

  İmmediately after the intervention at 4 Menstrual Cycle

Study Arms (2)

Heat Treatment Group

EXPERIMENTAL

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.

Other: Heat Treatment

Control Group

NO INTERVENTION

No Intervention

Interventions

Heat Treatment OTHER

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

Heat Treatment Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Hülya TÜRKMEN

Balıkesir, 10100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea; Fever

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer (PhD)

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 1, 2020
• Study Start: March 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)