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

NCT05408611 | Completed DMC

• 1 other identifier: 000
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Pain; Dysmenorrhea Primary; Signs and Symptoms

Keywords

Primary dysmenorrhea; acupressure; pain; menstrual symptoms; general comfort

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  Pain will be evaluated by using the "Visual Analog Skala (VAS)" . The Visual Analog Scale is used to measure the pain perceived by the person. There is a 10 cm mark on the one end of the scale, where there is no pain (zero), and on the other end there is the most severe (10) pain. Between the (100 mm.) part, the individual can indicate his or her pain by drawing a line, putting a dot or pointing. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters, and the value found indicates the severity of the individual's pain. In the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, while 75-100 mm indicates severe pain.

  change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).

• Menstrual Symptom Questionnaire (MSQ)

  Menstrual symptoms will be evaluated by using the "Menstrual Symptom Questionnaire ". The Menstrual Symptom Questionnaire was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. The scale, which is a five-point Likert type and consists of 24 items, was updated by Negriff et al. in 2009 by re-evaluating its factor structure and usability. The MSQ score is calculated by taking the total mean score of the items in the scale. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The original Cronbach's Alpha value of the scale was .86 and had three sub-dimensions: "Negative Effects/Somatic Complaints", "Menstrual Pain" and "Abdominal Pain". The Turkish validity and reliability study of the Menstruation Symptom Questionnaire was performed by Güvenç et al. in 2014. Two items (6th and 17th items) in the original of the scale were removed from the scale because they had an item-total score correlation of less than 0.30. The scale

  change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).

Secondary Outcomes (1)

• General Comfort Scale (GAS)

  change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).

Study Arms (2)

Experimental (acupressure) group

EXPERIMENTAL

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)

Other: Acupressure

Plasebo group

PLACEBO COMPARATOR

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)

Other: Placebo acupressure

Interventions

Acupressure 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.

Experimental (acupressure) group

Placebo acupressure OTHER

Placebo acupressure is manual pressure applied to unreal acupressure points.

Plasebo group

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Yenişehir, Mersin, 33140, Turkey (Türkiye)

Location

Related Publications (1)

• Aksoy-Can A, Buldum A, Abic A, Vefikulucay-Yilmaz D. The effect of acupressure on pain, menstrual symptoms, and comfort in adolescents with primary dysmenorrhea: a single-blind randomized controlled trial. BMC Complement Med Ther. 2025 Jul 2;25(1):221. doi: 10.1186/s12906-025-04965-0.

  PMID: 40605053 DERIVED

Related Links

• The effects of acupressure on severity of primary dysmenorrhea
• Effectıveness Of Abdomınal Stretchıng Exercıse And Sanyınjıao Acupressure To Relıeve Dysmenorrhea Paın

MeSH Terms

Conditions

Pain; Signs and Symptoms

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PhD

Model Details: Prospective, parallel, two arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: April 17, 2023
• Primary Completion: August 15, 2023
• Study Completion: November 15, 2023
• Last Updated: January 9, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)