The Effect of the Menstrual Belt Stress Ball on Pain in Women With Dysmenorrhea

NCT06949397 | Completed

• 1 other identifier: GEDIKU-EBE-ME-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted as a randomized controlled quasi-experimental study to determine the effect of hot massage menstrual belt and stress relief ball application on pain intensity in women with dysmenorrhea. The study will include 105 women with dysmenorrhea (midwife, nurse, doctor, cleaning staff, secretary) who meet the inclusion criteria. Female participants between the ages of 18-45 will be randomly divided into three groups as experimental group 1 (n=35), experimental group 2 (n=35) and control group (n=35) by envelope method. Data will be collected using Informed Consent Form, Descriptive Information Form, Visual Pain Scale (VAS), Dysmenorrhea Impact Scale-Revised Short Form (DIS-R) and Menstrual Symptoms Scale. Descriptive Information Form, Visual Pain Scale (VAS), Dysmenorrhea Impact Scale-Revised Short Form (DIS-R) and Menstrual Symptom Scale will be applied to the three groups before the application. During the application, experimental group 1 will be given a menstrual belt with electric waist heating and vibration for 20 minutes. Experimental group 2 will be given a stress-relieving squeezing ball to feel its soft structure for the same period of time.The third group was determined as the control group and no application will be made. After the application, the participants will be asked to rate their pain intensity using the Visual Pain Scale (VAS) and record their pain scores.

Conditions

Education

Keywords

pain; dismenore; Menstruation belt; stress ball

Outcome Measures

Primary Outcomes (1)

• change in the vas visual pain scale of the research group after using the menstrual belt

  Women in the research group applied menstrual belt and stress ball

  20 minutes after applying the menstrual belt and stress ball

Study Arms (3)

Menstrual belt group

EXPERIMENTAL

Before any procedure was performed, the women included in the Experiment 1 group were administered the Volunteer Information and Consent Form, Introductory Information Form, Visual Pain Scale, Dysmenorrhea Impact Scale-Revised Short Form (DIS-R), and Menstruation Symptom Scale when they complained of dysmenorrhea during menstruation. In participants with dysmenorrhea pain of 4 or more, the electric menstrual belt that applies hot massage was used to all participants in a way that it did not come into direct contact with the skin over the top of the clothes during the 20 minutes planned for women to relieve pain on the day of menstruation. After the application was over, the participant was asked to fill out the Visual Pain Scale (VAS) form again to evaluate the effect of the use of the menstrual belt on the dysmenorrhea complaint felt during menstruation.

Other: Change in VAS voice performance score following the characteristics of the menstrual cycle of two women

Stress Relief Ball group

EXPERIMENTAL

The women included in the Experimental 2 group were administered the Volunteer Information and Consent Form, Introductory Information Form, Visual Pain Scale, Dysmenorrhea Impact Scale-Revised Short Form (DERS-R), and Menstruation Symptom Scale when they complained of dysmenorrhea during menstruation before any procedure was performed. At this stage, dysmenorrhea complaint was given to the participant with a score of 4 and above. On the day of menstruation, when dysmenorrhea complaint started, the women were given the anti-stress soft ball toy to squeeze in their hands within the planned 20 minutes. After the application was over, the participant was asked to fill out the Visual Pain Scale (VAS) form again to evaluate the effect of the use of anti-stress soft ball on the dysmenorrhea complaint experienced during menstruation.

Other: Change in VAS voice performance score following the characteristics of the menstrual cycle of two women

Control group

NO INTERVENTION

Women enrolled in the control group did not undergo any procedure, and before and after the procedure, the informed consent form, the introductory information form, the visual pain scale, the Dysmenorrhea Impact Scale-Revised Short Form (DIS-R), and the menstrual symptom scale were used. Women with a Dysmenorrhea Impact Score of 4 and above were monitored for 20 minutes without intervention by starting a stopwatch on the telephone. At the end of the 20-minute follow-up period given to the control group, the stopwatch on the phone was stopped. The control group was asked to fill out the Visual Pain Scale (VAS) form again to evaluate the dysmenorrhea complaint scores after the follow-up was over. After answering the questions in the data collection forms, the individual questions were answered.

Interventions

Change in VAS voice performance score following the characteristics of the menstrual cycle of two women OTHER

application of menstrual belt and stress ball to women in the research group

Also known as: studying the effect of the stress ball

Menstrual belt group; Stress Relief Ball group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not being pregnant
• Being a woman between the ages of 18-45
• Duration of the menstrual cycle being 1-7 days
• Duration of the menstrual cycle being between 26-30 days
• Complaint of pain during the menstrual period
• Not having entered menopause
• Having the symptom of dysmenorrhea
• Not having any systemic disease
• Read- being an author
• being able to communicate in Turkish
• being willing to participate in the study
• not using drugs containing analgesics during the mentrual cycle
• giving 4 points or more (severe pain) to mentruation pain out of 10 points on the VAS Visual Pain Scale

You may not qualify if:

• Being pregnant
• Having entered menopause
• Having no pain problems during the mentrual cycle
• Mentrual cycle duration lasting from 26 to more than 30 days
• Mentrual day being less than 3 and more than 7
• Having any systemic disease
• Using drugs containing analgesics during the mentrual cycle
• Using psychotherapeutic drugs
• Having secondary dysmenorrhea
• Giving mentrational pain 3 points or less (severe pain) out of 10 points on the VAS Visual Pain Scale

Sponsors & Collaborators

• Istanbul Gedik University: lead

Study Sites (1)

Gedik University

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (9)

• Güvenç, G., Seven, M., & Akyüz, A. (2014). Menstrüasyon Semptom Ölçeği'nin Türkçe'ye Uyarlanması. TAF Preventive Medicine Bulletin, 13(5).

  BACKGROUND

• Gün Kakaşçı, Ç., & Coşkuner Potur, D. İ. L. E. K. (2022). Menstruation Impact Scale Development. Medical records-international medical journal (Online), 4(3).

  BACKGROUND

• Güvey, H. (2019). Adölesanlarda primer dismenore ve tedavi tedavileri. Jinekoloji-Obstetrik ve Neonatoloji Tıp Dergisi, 16 (3), 160-166

  BACKGROUND

• Gün, Ç. (2014). Dismenore etkilenmişlik ölçeğinin geliştirilmesi (Doctoral dissertation, Doktora Tezi, İstanbul).

  BACKGROUND

• Boztaş Elverişli, G. (2022). Primer dismenoreli kadınlarda farmakolojik ve non-farmakolojik tedavinin etkinliğinin karşılaştırılması.

  BACKGROUND

• Yürekdeler Şahin, N. (2017). Yüksek frekanslı TENS ile konnektif doku manipulasyonunun primer dismenore üzerine etkilerinin karşılaştırılması.

  BACKGROUND

• Şaşmaz, Y. (2022). Çevrimiçi yoga temelli egzersiz programının primer dismenoreli kadınlarda etkisinin araştırılması (Master's thesis, İstanbul Medipol Üniversitesi, Sağlık Bilimleri Enstitüsü).

  BACKGROUND

• Potur DC, Bilgin NC, Komurcu N. Prevalence of dysmenorrhea in university students in Turkey: effect on daily activities and evaluation of different pain management methods. Pain Manag Nurs. 2014 Dec;15(4):768-77. doi: 10.1016/j.pmn.2013.07.012. Epub 2013 Nov 11.

  PMID: 24230963 BACKGROUND

• Potur, D. C. (2009). Lokal düşük Doz ısı uygulamasının Dismenore üzerine Etkileri (Doctoral dissertation, Marmara Universitesi (Turkey)).

  BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Melek ERDOĞDU

  Gedik University School of Nursing İstanbul, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: April 30, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-03

Locations

TU (1)