Effect of Acupressure-Ice Message on Primary Dysmenorrhea

NCT06578013 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005306
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to determine the effect of acupressure ice massage on primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (3)

• Pain intensity assessment

  It will be assessed for each participant in both groups (A \& B) before and after treatment, using the visual analogue scale (VAS). The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of " no pain at all " and " worst pain imaginable ". It's simplicity, reliability and validity as well as its ratio scale properties make the VAS the optional tool for describing pain intensity.

  3 months

• Assessment of pain pressure threshold

  A pressure algometer will be used to measure pain pressure thresholds (PPTs) for all participants in both groups before and after treatment, coinciding with peak menstrual pain on the first day of menstruation. Six specific points around the umbilicus and lower back will be assessed, with each point measured twice using a 1-cm² probe applied at 30kPa/s. The areas will be cleaned with alcohol before testing. Two points will be measured 4cm bilaterally from the umbilicus, two more 4cm below these, one 4cm below the umbilicus, and one in the lumbar region at S2-S4. The mean values of these points will be used for PPT data analysis.

  3 months

• Menstrual distress questionnaire (MDQ)

  It will be used pre and post- treatment to assess the severity of symptoms of primary dysmenorrhea for all participants in both groups (A \& B). The MDQ consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5 point rating scale from 0-4. For each items, there is 5 options i.e. No, mild, moderate, severe and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven sub-scales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, arousal control). Overall Score was interpreted as follows :\< 50 - mild , 50 to 70 - moderate and \>70 severe.

  3 months

Study Arms (2)

acupressure ice massage + pelvic rocking exercises

EXPERIMENTAL

It will include 25 participants suffering from primary dysmenorrhea who will receive acupressure ice massage on SP6 and L14 acupoints, 10 minutes on each point for 20 minutes each session, 5 sessions per cycle (through the 5 days before menstruation) for 3 consecutive menstrual cycles, in addition to pelvic rocking exercises, 15 minute/session, 3 times /week, for 3 successive menstrual cycles.

Other: acupressure ice massage; Other: pelvic rocking exercises

pelvic rocking exercises

ACTIVE COMPARATOR

It will include 25 participants suffering from primary dysmenorrhea, who will perform pelvic rocking exercises only, 15 minutes/session, 3 times /week, for 3 successive menstrual cycles.

Other: pelvic rocking exercises

Interventions

acupressure ice massage OTHER

* It will be used for participants in group (A), 2 cm diameter circular ice pieces will be placed inside plastic bags and covered with a thin gauze to prevent moisture transmission and direct ice contact with the skin to apply ice massage. * Ice massage will carried out rotationally each 1 minute (30 seconds clockwise and 30 seconds counterclockwise) on L14 point for 10 minutes and on SP6 point for another 10 minutes.

acupressure ice massage + pelvic rocking exercises

pelvic rocking exercises OTHER

* Pelvic rocking exercise will be used for all participants in both groups (A \& B). * Each participant will be encouraged to lie down on her back on matrix with a pillow under head then bend her knees and keep her foot flat on the floor and place one hand under curve of her back and the other hand on the top of. her abdomen then tighten buttocks and abdominal muscles simultaneously. After that each participant will be encouraged to inhale and hold (1-2-3-4) then exhale and hold 4-3-2-1 then relax muscles and feel her back flat on the underneath hand. Finally, each participant will be encouraged to repeat the last two steps about 10 times each session. * The exercise will be repeated for 15times/ session, 3 times /week, for 3 successive menstrual cycles.

acupressure ice massage + pelvic rocking exercises; pelvic rocking exercises

Eligibility Criteria

• Age: 17 Years - 25 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fifty adolescents' females who are clinically diagnosed as primary dysmenorrhea.
• Their ages will be ranged from 17-25 years old.
• Their BMI will be less than 30 kg/m².
• All of them are virgin.
• Their pain level will be more than 3 on visual analogue scale.
• Having mild to moderate score on Menstrual Distress questionnaire (MDQ) ( ≥ 50).
• Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding).

You may not qualify if:

• Systematic chronic diseases or any pelvic inflammatory diseases.
• Secondary dysmenorrhea.
• Menstrual irregularity.
• Nerve damage resulting in loss of feeling.
• Swelling, scar or skin infection.
• Diabetic patients.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Doaa Ashraf Abd El-Ghany

Cairo, Egypt

Location

Study Officials

• Azza Barmoud Nashed Kassab, PhD

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Doaa Ashraf Abd El-Ghany, B.Sc

CONTACT

01090052117; doaaashrafabdelghany@gmail.com

Manal Ahmed El-Shafei, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 15, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

EG (1)