Benson Relaxation Technique Effectiveness on Pain and Quality of Life Post Reconstructive Mammoplasty

NCT07032883 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005668
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate effectiveness of benson relaxation technique on pain and quality of life post mammoplasty.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Assessment of pain severity

  Visual analogue scale is a popularly used standardized scale for assessing pain intensity. It is 10 point horizontal line scale ranging from 0 to 10. The participants of both groups will be asked to mark the point representing their pain level before and after the intervention, with 0 meaning no pain and 10 meaning the worst pain.

  4 weeks

• Assessment of quality of life

  The WHOQOL-BREF scale will be used to assess quality of life for all participants before and after the treatment program It is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The highest possible score on the WHOQOL-BREF scale is 100. This score represents the best possible quality of life.

  4 weeks

Study Arms (2)

Benson relaxation technique and routine physiotherapy program group

EXPERIMENTAL

This group will receive Benson relaxation technique for duration up to 20 min twice daily in addition to medical therapy and a routine physical therapy program for 40 minutes, twice daily for 4 weeks.

Other: Benson relaxation technique; Other: Routine physiotherapy program; Drug: Medications

routine physiotherapy program group

ACTIVE COMPARATOR

This group will receive medical therapy and a routine physical therapy program for 40 minutes, twice daily for 4 weeks.

Other: Routine physiotherapy program; Drug: Medications

Interventions

Benson relaxation technique OTHER

It will be performed every day, twice daily (in the morning and evening), for 4weeks, the Benson relaxation technique instruction included these steps. 1. Sit in a comfortable position. 2. Close their eyes. 3. Relax all their muscles beginning from the soles of the feet, moving forward up, and relax all parts of their body. (4 ) Breath through their nose, pay attention to the sound of their breathing, and say the word ''one'' quietly to themselves when the breath is out. (5) Continue for 20 min. the patients were instructed to check the time by opening their eyes. However, using an alarm was prohibited. The training sessions were held during the patients hospitalization period after one week from surgery, the technique continued during the hospitalization and after discharge from the hospital.

Benson relaxation technique and routine physiotherapy program group

Routine physiotherapy program OTHER

The participants will receive routine physical therapy program (gentle stretching, manual therapy, mobility and strengthening exercises and posture training) for 40 minutes , for 4 weeks.

Benson relaxation technique and routine physiotherapy program group; routine physiotherapy program group

Medications DRUG

the participants will receive the following medications: 1. Antibiotic: Ancef 1 g intravenous (IV) ( cefazolin) intravenous post-surgery every 8 hours for 24 hours. If allergic to ampicillin /cephalosporins clindamycin IV 600\_900 mg every 8 hours for 24 hours. Then continue oral with keflex 1g tablets (cephalexin) twice daily for 7 days. 2. Anti-inflammatory: Adolor ( ketorolac) 15\_30 mg IV every 6 hours up to 5 days post-operation ( not exceed 120 mg/day) then followed by oral celecoxib 200 mg once or twice daily till pain subsides. 3. paracetamol 500\_1000 mg I.V every 6 hours for 5 days (Not exceed 4000 mg / day) Then followed by oral paracetamol tablets till pain subsides. 4. Zurcal 40 mg IV (pantoprazol) then followed by oral zurcal tablets.

Benson relaxation technique and routine physiotherapy program group; routine physiotherapy program group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Only female patients underwent reconstruction mammoplasty will participate in the study.
• Female patients who stopped chemotherapy at least one month before participation in the study.
• Female patients with chronic pain following cosmetic breast surgery.
• All patients who will accept to participate in the study after one week from operation.

You may not qualify if:

• Patients have irritable bowel syndrome.
• Patients have urinary incontinence.
• Chronic diseases like multiple sclerosis, polyneuropathy , diabetes and fibromyalgia.
• Patients have cognitive disorder.
• Patients with chronic and severe back pain.
• Sepsis with complications postoperative hemodynamics.
• Patients take anti-psychotic drugs.
• Patients take hypnotic drugs.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mohamed Abd El-Monem Morad

Tanta, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Sameh M El Taher, Professor

  Ain Shams University

  STUDY DIRECTOR

• Haidy N Ashem, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mohamed Abd El-Monem, Master

CONTACT

+201010615984; mohamedabdelmonem224@gmail.com

Marwa M AbdelHamid, PHD

CONTACT

+201027889255; marwa.mahdy@pt.cu.edu.eg

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: June 13, 2025
• First Posted: June 24, 2025
• Study Start: June 25, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 15, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

EG (1)