Effects of Dry Heat Application for Menstrual Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Reproductive Health
• Intervention / Treatment: Behavioral: Dry heat application

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Manisa
    • Yunusemre, Manisa, Turkey
      • Dilay Açıl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 days.
Menstrual Symptoms.	Menstrual Symptom Questionnaire was used.	10 days.

Collaborators and Investigators

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

Publications and helpful links

General 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.
• Karout 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.
• Jo 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.
• Alsaleem 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): November 29, 2019
• Study Completion (Actual): November 29, 2019

Study Registration Dates

• First Submitted: December 10, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Menstruation; Hot pack application
• Other Study ID Numbers: 2019-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data will be given if it's necessary and if it is not problem for ethical office.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No