Effect of Hegu Point Ice Massage and Music in Dysmenorrhea

NCT ID: NCT05686460

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2022-06-30

Brief Summary

Dysmenorrhea, a gynecological health problem that is frequently observed in adolescents and young adult women and often cannot be diagnosed is defined as pelvic pain associated with menstruation.

Providing analgesia without using pharmacological treatment is the leading aim of health care and can reduce drug-related complications. Therefore, nurses' awareness of the use of complementary and alternative medicine should be raised and the methods used should be based on evidence. Our search for studies in which the effects of listening to music and ice massage applied to the Hegu point on pain management in individuals with dysmenorrhea were investigated demonstrated that the number of such studies in the literature is not many. We think that the present study is important in terms of increasing the comfort levels of individuals with dysmenorrhea, basing the applications on evidence and contributing to the literature. It was conducted to compare the effects of ice massage applied to the Hegu point and music on pain and comfort levels in nursing students with dysmenorrhea.

Detailed Description

Dysmenorrhea, a gynecological health problem that is frequently observed in adolescents and young adult women and often cannot be diagnosed, is defined as pelvic pain associated with menstruation. The prevalence of dysmenorrhea is reported to vary between 50% and 90% in women of reproductive age. Dysmenorrhea and the symptoms accompanying dysmenorrhea cause significant economic losses by leading to both work and school absenteeism. Particularly in adolescents, due to dysmenorrhea, participation in sports and social activities is restricted, indicators of academic performance such as school absenteeism, school success, concentration, productivity are negatively affected, and thus their levels of general comfort and quality of life decrease. On the other hand, pharmacological treatment options used in the treatment of dysmenorrhea are very few. On top of this, the effectiveness of these treatment options is still debated. Since the medication used in the pharmacological treatment of dysmenorrhea has various side effects, using non-pharmacological treatments in addition to pharmacological treatment in the management of dysmenorrhea would be beneficial.

Cold application is one of the effective, simple, inexpensive and reliable non-pharmacological methods used to reduce pain, with few complications or no side effects. The Hegu point, the most important pain relief point of the body, can be stimulated in all painful conditions. Another low-risk and low-cost nonpharmacological method for standard care used in pain management is the music medicine.

This randomized clinical trial was designed to determine the effects of ice massage applied to the Hegu point and music on dysmenorrhea, compared to a control group that no intervention in women of 18 years or older from the the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ice massage

The application applied 2 minutes of ice massage 7 times at 15-second intervals. The procedure was performed once on the first day and once on the second day of menstruation.

Group Type: EXPERIMENTAL

ice massage

Intervention Type: BEHAVIORAL

After the students who met the sample selection criteria applied Student Information Form. On the first day of the participating students' menstruation, prior to the application (when the pain started), the Visual Analogue Scale (VAS), General Comfort Questionnaire (GCQ) and Dysmenorrhea Follow-up Form were filled in at the pre-test. The Hegu point of the participating students was detected with the acupuncture point finder. Ice cubes whose dimensions were 2x2x2 cm were wrapped with gauze and placed in a plastic bag. Vaseline® jelly was spread on the application area. The application applied 2 minutes of ice massage 7 times at 15-second intervals. The participants' pain levels were assessed three times, as soon as the application was over, 30 and 60 minutes after the application (Post-test).

On the second day of menstruation, the participants were asked to fill in the VAS, GCQ, and Effects of Dysmenorrhea Scale (EDS).

music medicine

Depending on their preference, each participant wearing personalized headphones was played instrumental music in the pre-menstruation period for 30 minutes. The procedure was performed once on the first day and once on the second day of menstruation.

Group Type: EXPERIMENTAL

music medicine

Intervention Type: BEHAVIORAL

After the students who met the sample selection criteria applied Student Information Form. On the first day of the participating students' menstruation, prior to the application (when the pain started), the Visual Analogue Scale (VAS), General Comfort Questionnaire (GCQ) and Dysmenorrhea Follow-up Form were filled in at the pre-test. Depending on their preference, each participant wearing personalized headphones was played instrumental music in the pre-menstruation period for 30 minutes. The volume of the music was adjusted based on the verbal feedback or facial expressions of the students. The participants' pain levels were assessed three times, as soon as the application was over, 30 and 60 minutes after the application (Post-test). On the second day of menstruation, the participants were asked to fill in the VAS, GCQ, and Effects of Dysmenorrhea Scale (EDS).

control

On the first and second days of menstruation, their pain levels of were assessed 4 times: when the pain started (pre-test), and then 30, 60 and 90 minutes after the pain started.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ice massage

After the students who met the sample selection criteria applied Student Information Form. On the first day of the participating students' menstruation, prior to the application (when the pain started), the Visual Analogue Scale (VAS), General Comfort Questionnaire (GCQ) and Dysmenorrhea Follow-up Form were filled in at the pre-test. The Hegu point of the participating students was detected with the acupuncture point finder. Ice cubes whose dimensions were 2x2x2 cm were wrapped with gauze and placed in a plastic bag. Vaseline® jelly was spread on the application area. The application applied 2 minutes of ice massage 7 times at 15-second intervals. The participants' pain levels were assessed three times, as soon as the application was over, 30 and 60 minutes after the application (Post-test).

On the second day of menstruation, the participants were asked to fill in the VAS, GCQ, and Effects of Dysmenorrhea Scale (EDS).

Intervention Type: BEHAVIORAL

music medicine

After the students who met the sample selection criteria applied Student Information Form. On the first day of the participating students' menstruation, prior to the application (when the pain started), the Visual Analogue Scale (VAS), General Comfort Questionnaire (GCQ) and Dysmenorrhea Follow-up Form were filled in at the pre-test. Depending on their preference, each participant wearing personalized headphones was played instrumental music in the pre-menstruation period for 30 minutes. The volume of the music was adjusted based on the verbal feedback or facial expressions of the students. The participants' pain levels were assessed three times, as soon as the application was over, 30 and 60 minutes after the application (Post-test). On the second day of menstruation, the participants were asked to fill in the VAS, GCQ, and Effects of Dysmenorrhea Scale (EDS).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Having menstruation regularly (between 21 and 35 days),
• Not using traditional and complementary treatments such as analgesics or massage during the application,
• Not having a diagnosed psychiatric problem and a history of endometriosis in the past,
• Not having infection and ovarian cyst / tumor, not having a neuropathic problem that might cause diabetes or nerve damage,
• Being over 18 years of age and agreeing to participate in the study.

Exclusion Criteria

• Having hearing problems,
• Having connective tissue diseases,
• Having bleeding and coagulation disorders,
• Having fractures in the hand and arm to undergo therapy,
• Having sensitivity to cold,
• Using oral contraceptives.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 33 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Celal Bayar University

OTHER

Sponsor Role: lead

Responsible Party

Sevgi Çetin

Research Assistant Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevgi PAKİŞ ÇETİN, Res Asis Dr

Role: PRINCIPAL_INVESTIGATOR

Celal Bayar University

Locations

Celal Bayar University

Manisa, Uncubozköy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CBU-PAKİSCETİN-1

Identifier Type: -

Identifier Source: org_study_id