Breast CancerNCT07032883
Benson Relaxation Technique Effectiveness on Pain and Quality of Life Post Reconstructive Mammoplasty
A study testing Benson relaxation technique, Routine physiotherapy program and Medications in people with Breast Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate effectiveness of benson relaxation technique on pain and quality of life post mammoplasty. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Benson relaxation technique, Routine physiotherapy program and Medications
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to evaluate effectiveness of benson relaxation technique on pain and quality of life post mammoplasty.
Read the 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
- Being tested
- Benson relaxation technique, Routine physiotherapy program, Medications
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson relaxation techniqueOther
It will be performed every day, twice daily (in the morning and evening), for 4weeks, the Benson relaxation technique instruction included these steps.
- Sit in a comfortable position.
- Close their eyes.
- 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 programOther
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.
MedicationsDrug
the participants will receive the following medications:
- 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.
- 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.
- 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.
- Zurcal 40 mg IV (pantoprazol) then followed by oral zurcal tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine physiotherapy program; Drug: Medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd El-Monem Morad, Cairo University
- Investigators
- Sameh M El Taher, Professor, Study director, Ain Shams UniversityHaidy N Ashem, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032883
- Sponsor's protocol ID
- P.T.REC/012/005668
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benson Relaxation Technique Effectiveness on Pain and Quality of Life Post Reconstructive Mammoplasty
- ClinicalTrials.gov ID
- NCT07032883
- Acronym / sponsor ID
- P.T.REC/012/005668
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benson relaxation technique and routine physiotherapy program group | Experimental | Other: Benson relaxation technique, Other: Routine physiotherapy program, Drug: MedicationsThis 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. |
| routine physiotherapy program group | Active comparator | Other: Routine physiotherapy program, Drug: MedicationsThis group will receive medical therapy and a routine physical therapy program for 40 minutes, twice daily for 4 weeks. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benson relaxation techniqueIt 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. | Other | Benson relaxation technique and routine physiotherapy program group |
| Routine physiotherapy programThe participants will receive routine physical therapy program (gentle stretching, manual therapy, mobility and strengthening exercises and posture training) for 40 minutes , for 4 weeks. | Other | Benson relaxation technique and routine physiotherapy program group, routine physiotherapy program group |
| Medicationsthe 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. | Drug | Benson relaxation technique and routine physiotherapy program group, routine physiotherapy program group |
Primary outcome
Assessment of pain severity
Time frame: 4 weeks
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.
Assessment of quality of life
Time frame: 4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sameh M El Taher, Professor study director
Ain Shams University
Haidy N Ashem, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benson relaxation technique, Routine physiotherapy program and Medications in people with Breast Cancer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abd El-Monem, Master (+201010615984, mohamedabdelmonem224@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain severity (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.