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

NCT ID: NCT07032883

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2026-02-15

Brief Summary

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

Detailed Description

Pain post reconstructive mammoplasty is common and has an impact on psychosocial aspects, anxiety, sleep disorders and activities of daily living(ADL),as a result patients suffer from impairment in quality of life.

To manage pain pharmaceutical and non-pharmaceutical interventions could be used.

Benson relaxation is a deep breathing relaxation therapy that has been developed by involving a person's belief factor. It works by shifting the focus of pain so that the body becomes relaxed, this can increase endogenous analgesics and be strengthened again by reciting spiritual sentences that provide calm.

Benson relaxation technique has a major effect on reducing anxiety, depression, and improving quality of life and psychological factors. Furthermore, this technique is easy to learn and no side effects have been reported.

Conditions

Breast Cancer

Study Design

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

Study Groups

Benson relaxation technique and routine physiotherapy program group

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.

Group Type: EXPERIMENTAL

Benson relaxation technique

Intervention Type: 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.

Routine physiotherapy program

Intervention Type: 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.

Medications

Intervention Type: 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.

routine physiotherapy program group

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

Group Type: ACTIVE_COMPARATOR

Routine physiotherapy program

Intervention Type: 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.

Medications

Intervention Type: 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.

Interventions

Benson relaxation technique

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.

Intervention Type: OTHER

Routine physiotherapy program

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.

Intervention Type: OTHER

Medications

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abd El-Monem Morad

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh M El Taher, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Haidy N Ashem, Professor

Role: STUDY_CHAIR

Cairo University

Locations

Mohamed Abd El-Monem Morad

Tanta, , Egypt

Countries

Egypt

Central Contacts

Mohamed Abd El-Monem, Master

Role: CONTACT

mohamedabdelmonem224@gmail.com

+201010615984

Marwa M AbdelHamid, PHD

Role: CONTACT

marwa.mahdy@pt.cu.edu.eg

+201027889255

Other Identifiers

P.T.REC/012/005668

Identifier Type: -

Identifier Source: org_study_id