Clinical trial NCT05664048: Effects of Dry Heat Application for Menstrual Symptoms
Official title: Effects of Dry Heat Application on Menstrual Symptoms and Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Health
Keywords: Menstruation
Hot pack application
Pain
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain due to menstruation.
timeFrame: 10 days.
measure: Menstrual Symptoms.
timeFrame: 10 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Yunusemre
country: Turkey
facility: Dilay Açıl
state: Manisa
Study officials:
affiliation: Celal Bayar University
name: Kıvan Çevik Kaya, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.