Effect of Acupressure-Ice Message on Primary Dysmenorrhea

NCT ID: NCT06578013

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2024-12-15

Brief Summary

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

Detailed Description

Dysmenorrhea is considered the most common gynecological complaint by young women and affects approximately 60-80% of the female population. Around 8-18% of that population report intense discomfort, causing absenteeism in several daily activities while suffering pain.

Analgesics are considered the first line of treatment, but they are known for their undesirable effects such as renal, cardiovascular and gastrointestinal complications that can negatively affect patients' health. Physical therapy has alternative techniques that assist in analgesia in a practical and effective way; among them is acupressure and cryo therapy.

The effect of application of ice on the skin has a direct action on neurons and pain receptors, lowering the speed and the number of nerve impulses. This effect is due to its action on the gate control of pain mechanism, leading to the release of endorphins and enkephalins that are pain-relieving substances.

It was proved from previous studies that using ice massage on L14 or SP6 points reduce pain intensity in females suffering from PD. So, further studies are needed to investigate the effect of acupressure ice massage not only on pain intensity but also on other symptoms severity and quality of life of females suffering from PD. Therefore, this study will be conducted for this issue which will be of valuable benefits for medical service organization and increase body of knowledge of physical therapy in scientific field.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

acupressure ice massage + pelvic rocking exercises

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.

Group Type: EXPERIMENTAL

acupressure ice massage

Intervention Type: 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.

pelvic rocking exercises

Intervention Type: 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.

pelvic rocking exercises

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.

Group Type: ACTIVE_COMPARATOR

pelvic rocking exercises

Intervention Type: 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.

Interventions

acupressure ice massage

• 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.

Intervention Type: OTHER

pelvic rocking exercises

• 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Ashraf Abd El-Ghany

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azza Barmoud Nashed Kassab, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

Doaa Ashraf Abd El-Ghany

Cairo, , Egypt

Countries

Egypt

Central Contacts

Doaa Ashraf Abd El-Ghany, B.Sc

Role: CONTACT

doaaashrafabdelghany@gmail.com

01090052117

Manal Ahmed El-Shafei, PhD

Role: CONTACT

Facility Contacts

Doaa Ashraf Abd El-Ghany, B.Sc

Role: primary

doaaashrafabdelghany@gmail.com

01090052117

Manal Ahmed El-Shafei, PhD

Role: backup

Other Identifiers

P.T.REC/012/005306

Identifier Type: -

Identifier Source: org_study_id