Clinical trial NCT05408611: The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents with Primary Dysmenorrhea
Official title: The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents with Primary Dysmenorrhea: a Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Dysmenorrhea Primary
Signs and Symptoms
Keywords: Primary dysmenorrhea
acupressure
pain
menstrual symptoms
general comfort
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 56
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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?

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
measure: Menstrual Symptom Questionnaire (MSQ)
timeFrame: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Secondary outcomes:
measure: General Comfort Scale (GAS)
timeFrame: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Other outcomes:
Locations:
city: Yenişehir
country: Turkey
facility: Mersin University
state: Mersi̇n
Study officials:
References: