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Clinical Trials/NCT05664048
NCT05664048
Completed
Not Applicable

Effects of Dry Heat Application on Menstrual Symptoms and Pain: A Randomized Controlled Trial

Celal Bayar University1 site in 1 country65 target enrollmentSeptember 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Reproductive Health
Sponsor
Celal Bayar University
Enrollment
65
Locations
1
Primary Endpoint
Pain due to menstruation.
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2019
End Date
November 29, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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