Effects of Dry Heat Application for Menstrual Symptoms

Sponsor
Celal Bayar University (Other)
Overall Status
Completed
CT.gov ID
NCT05664048
Collaborator
(none)
65
1
2
2
33

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dry heat application
N/A

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

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effects of Dry Heat Application on Menstrual Symptoms and Pain: A Randomized Controlled Trial
Actual Study Start Date :
Sep 30, 2019
Actual Primary Completion Date :
Nov 29, 2019
Actual Study Completion Date :
Nov 29, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dry heat application group

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.

Behavioral: Dry heat application
Self- dry heat application on the foot during menstrual period with pain.

No Intervention: Control group

The students in the control group completed only the related forms ("Visual Analog Scale" and "Menstrual Symptom Questionnaire") in the period of the menstruation.

Outcome Measures

Primary Outcome Measures

  1. Pain due to menstruation. [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.

  2. Menstrual Symptoms. [10 days.]

    Menstrual Symptom Questionnaire was used.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 22 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • analgesics during the study

  • not agree to participate in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dilay Açıl Yunusemre Manisa Turkey

Sponsors and Collaborators

  • Celal Bayar University

Investigators

  • Principal Investigator: Kıvan Çevik Kaya, Assoc.Prof., Celal Bayar University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Celal Bayar University
ClinicalTrials.gov Identifier:
NCT05664048
Other Study ID Numbers:
  • 2019-045
First Posted:
Dec 23, 2022
Last Update Posted:
Dec 23, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Celal Bayar University

Study Results

No Results Posted as of Dec 23, 2022