Effects of Dry Heat Application for Menstrual Symptoms

NCT05664048 | Completed DMC

• 1 other identifier: 2019-045
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Reproductive Health

Keywords

Menstruation; Hot pack application; Pain

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Dry heat application group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Dry heat application BEHAVIORAL

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

Dry heat application group

Eligibility Criteria

• Age: 18 Years - 22 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• analgesics during the study
• not agree to participate in the study

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Dilay Açıl

Yunusemre, Manisa, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 19786516 BACKGROUND

• 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.

  PMID: 34749716 RESULT

• 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.

  PMID: 30389956 RESULT

• 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.

  PMID: 30234051 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kıvan Çevik Kaya, Assoc.Prof.

  Celal Bayar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 23, 2022
• Study Start: September 30, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)