The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents with Primary Dysmenorrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2023-11-15

Brief Summary

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In this study, it is planned to determine the effect of acupressure applied to adolescents with primary dysmenorrhea on pain, menstrual symptoms and general comfort. The research questions of the research are as follows; Research Questions

* Is there a difference in pain scores in the post-acupressure intervention group and the placebo group?
* Is there a difference between menstrual symptoms scores in the post-acupressure intervention group and the placebo group?
* Is there a difference between comfort scores in the intervention group and the placebo group after acupressure?
* Is there a difference between the pain scores of the intervention group according to time?
* Is there a difference between the menstrual symptoms scores of the intervention group according to time?
* Is there a difference between the comfort scores of the intervention group according to time? Is there a difference between the pain scores of the placebo group over time? Is there a difference between the menstrual symptoms scores of the placebo group over time?
* Is there a difference between the comfort scores of the placebo group over time?

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Detailed Description

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Methods:

Adolescents aged 14-17 years with primary dysmenorrhea will be randomly assigned to the acupressure and control groups. The study group (n=26) and placebo group (n=26) will be applied to the determined points in a certain order. The order of application is Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6). Acupressure will be applied to the adolescents in the groups individually for 18-20 minutes, twice a day in the first three days of their menstrual periods. The primary outcome measures of the study is the effect of acupressure on adolescent pain severity and menstrual symptoms. The secondary outcome measures of the study is the effect of acupressure on general comfort. Data collection forms will be applied four times in total for the second and third cycles, before and immediately after the acupressure application.

Conditions

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Pain Dysmenorrhea Primary Signs and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, two arm, randomized controlled clinical trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Adolescents who agreed to participate in the study by signing the voluntary consent form after being informed about the study will be assigned to the study or placebo groups by matching the numbers on the envelope according to their school numbers. In the study, a researcher will determine the acupressure and placebo points to be applied in adolescents and this researcher will make the first cycle application. Therefore, the researcher cannot be blinded. However, the participants will practice and be blinded without knowing whether the points to be treated are the acupressure point or the placebo point. Thus, the research will be carried out as a single-blind randomized controlled trial. When the research is completed, the data of the control and study groups (coded as A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statistician and the findings will be reported.

Study Groups

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Experimental (acupressure) group

Acupressure (complementary and integrative medicine method) Acupressure will be applied individually to the experimental group for 15 minutes three times a day for three menstrual cycles (approximately 3 months). Data collection forms will be applied 4 times in total, before the intervention, at the end of Cycle 1, cycle 2, and cycle 3 (each cycle is 28 days)

Group Type EXPERIMENTAL

Acupressure

Intervention Type OTHER

acupressure is a non-pharmacological method originating from traditional Chinese medicine. According to the National Cancer Institute, acupressure is defined as pressure / massage applied to certain parts of the body to control symptoms such as pain or nausea. The main purpose of acupressure is to stimulate the regions associated with the specific organ by applying pressure with energy channels called meridians.

Plasebo group

Placebo acupressure will be performed at any point within 1.5 cm of the actual acupressure points.

Placebo acupressure will be applied individually to the placebo group for 15 minutes three times a day for three menstrual cycles (approximately 3 months). Data collection forms will be applied 4 times in total, before the intervention, at the end of Cycle 1, cycle 2, and cycle 3 (each cycle is 28 days)

Group Type PLACEBO_COMPARATOR

Placebo acupressure

Intervention Type OTHER

Placebo acupressure is manual pressure applied to unreal acupressure points.

Interventions

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Acupressure

acupressure is a non-pharmacological method originating from traditional Chinese medicine. According to the National Cancer Institute, acupressure is defined as pressure / massage applied to certain parts of the body to control symptoms such as pain or nausea. The main purpose of acupressure is to stimulate the regions associated with the specific organ by applying pressure with energy channels called meridians.

Intervention Type OTHER

Placebo acupressure

Placebo acupressure is manual pressure applied to unreal acupressure points.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Those between the ages of 14-17,
* Willing to participate in the research,
* Open to communication,
* Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days),
* Menstrual pain severity is at least 4 according to the Visual Pain Scale,
* A score of 60 or more on the Menstruation Symptom Scale,
* Not using hormonal contraception and intrauterine device,
* Not pregnant and not experiencing pregnancy before,
* Does not have a systemic and chronic disease,
* Have not had a gynecological disorder or surgery before,
* Not using analgesics 6 hours before and during the study period,
* Body mass index \<30 kg/m2
* No physical/mental health problems that would prevent/limit acupressure and exercise,
* Not doing regular acupressure,
* No psychiatric problems
* Adolescents without active COVID-19 infection.

Exclusion Criteria

* Not between the ages of 14-17,
* Not willing to participate in the research,
* Closed to communication,
* Not having a regular menstrual period (not occurring at intervals of 21-35 days and lasting more or less than 3-8 days),
* Menstrual pain severity is less than 4 according to the Visual Pain Scale,
* A score below 60 on the Menstruation Symptom Scale,
* Using hormonal contraception and intrauterine device,
* Pregnant and experienced pregnancy before,
* Having a systemic and chronic disease,
* Have had a previous gynecological disorder or surgery,
* Using analgesics 6 hours before and during the study period,
* Body mass index ≥30 kg/m2
* Having physical/mental health problems that will prevent/limit acupressure and exercise,
* Regular acupressure
* Having a psychiatric problem
* Adolescents with active COVID-19 infection.

Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes