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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05408611
• Other study ID #: 000
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: October 2023
• Source: Mersin University
• Contact: Ahu AKSOY CAN, PhD
• Phone: 05444825892
• Email: aksoyahu91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Dysmenorrhea Primary
• Pain
• Signs and Symptoms

Intervention

Other:
• 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.
• Placebo acupressure
Placebo acupressure is manual pressure applied to unreal acupressure points.

Locations

Country	Name	City	State
Turkey	Mersin University	Yenisehir	Mersi?n

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, within 5 minutes after acupressure, at the end of Cycle 1 and cycle 2 (each cycle is 28 days).
Primary	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, within 5 minutes after acupressure, at the end of Cycle 1 and cycle 2 (each cycle is 28 days).
Secondary	General Comfort Scale (GAS)	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 Kuguoglu 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	change from before the intervention, within 5 minutes after acupressure, at the end of Cycle 1 and cycle 2 (each cycle is 28 days).

External Links

•   Effectiveness Of Abdominal Stretching Exercise And Sanyinjiao Acupressure To Relieve Dysmenorrhea Pain