Skip to main content
OpenTrials
Completed

NCT Number: NCT05408611

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

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Dysmenorrhea Primary Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Yenişehir, Mersin, 33140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo acupressure

Other

Placebo acupressure is manual pressure applied to unreal acupressure points.

Primary outcomes

  1. Visual Analog Scale (VAS)

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

    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.

  2. Menstrual Symptom Questionnaire (MSQ)

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

    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

Secondary outcomes

  1. General Comfort Scale (GAS)

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

    Comfort level will be evaluated by using the "General Comfort Scale (GAS)". It was developed by Kolcaba (1992) by taking the taxonomic structure, which includes three levels and four dimensions that make up the theoretical components of comfort, as a guide. The GAQ, which is suitable for Turkish society by Kuğuoğlu and Karabacak (2008), is of four and six-point Likert type, contains 24 positive and 24 negative items, and the response patterns are given in mixed form. The scale consists of three levels: relief (16 items), relaxation (17 items) and overcoming problems (15 items); It consists of four dimensions, namely the physical dimension (12 items), the psychospiritual dimension (13 items), the environmental dimension (13 items), and the sociocultural dimension (10 items). In the evaluation of the scale; Negative scores obtained are reverse coded and added up with positive items. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. The

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents with Primary Dysmenorrhea: a Single-Blind Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2022
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.