Oncology PatientsNCT06661239
Effect of Benson Relaxation Technique on Pain Level, Insomnia, Nausea, Vomiting, and Retching in Oncology Patients
A study testing benson relaxation and Routine care in unit in people with Oncology Patients and Relaxation Program, run by Damanhour University at 1 site in Egypt.
Trial summary
The benson Relaxation Technique (BRT), developed by Dr. Herbert Benson, is a method aimed at reducing stress and anxiety through a series of simple steps designed to elicit the "Relaxation Response." This response is a physiological state that counteracts the harmful effects of stress, characterized by decreased heart… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oncology Patients, Relaxation Program
- What is being tested?
- benson relaxation and Routine care in unit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aged 18-60 years
- diagnosed with cancer
- alert and able to communicate.
Who cannot join
- Patients who refused to participate in the study
- Patients with cognitive impairment
- Patient who unable to communicate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Benson Relaxation Technique on Pain Level, Insomnia, Nausea, Vomiting, and Retching in Oncology Patients Admitted to Intensive Care Units
The benson Relaxation Technique (BRT), developed by Dr. Herbert Benson, is a method aimed at reducing stress and anxiety through a series of simple steps designed to elicit the "Relaxation Response." This response is a physiological state that counteracts the harmful effects of stress, characterized by decreased heart rate, lower metabolism, and reduced breathing rate
Read the detailed description
The benson relaxation consisted of the following steps: (1) Sitting or lying down quietly in a comfortable position; (2) Closing eyes; (3) Deeply relaxing all muscles, beginning at the feet and progressing up to the face. Keeping them relaxed; (4) Breathing through the nose. Becoming aware of breathing. Focus on a word, phrase, a short prayer, or only breathing. (6) Continuing for 15 minutes. When finished, sit quietly for several minutes, at first with eyes closed and later with eyes opened. Do not stand up for a few minutes.
According to the agreement, the patients in both groups were required to perform the Benson relaxation technique regularly twice daily (morning and evening) for three days in a row. Each session lasted 15 minutes
- Conditions
- Oncology Patients, Relaxation Program
- Being tested
- benson relaxation, Routine care in unit
- Keywords
- benson relaxation, Oncology/ cancer patients, Clinical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benson relaxationBehavioural
The benson relaxation consisted of the following steps: (1) Sitting or lying down quietly in a comfortable position; (2) Closing eyes; (3) Deeply relaxing all muscles, beginning at the feet and progressing up to the face. Keeping them relaxed; (4) Breathing through the nose. (5) Maintaining a passive attitude and permitting relaxation to occur at its own pace; (6) Continuing for 15 minutes. When finished, sit quietly for several minutes, at first with eyes closed and later with eyes opened. Do not stand up for a few minutes.
According to the agreement, the patients in both groups were required to perform the Benson relaxation technique regularly twice daily (morning and evening) for seven days in a row. Each session lasted 15 minutes
Routine care in unitBehavioural
The routine care include in the unit will be delivered to control group
| Study group | Role | What they receive |
|---|---|---|
| The benson group | Experimental | Patients who received the intervention Receives: Behavioral: benson relaxation |
| Control group | Placebo comparator | Patients who receive routine care in units Receives: Behavioral: Routine care in unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rhodes Index of Nausea, Vomiting, and Retching
It is a self-report tool designed to assess the severity and impact of nausea, vomiting, and retching on patients' 5-point categorical scales, the interval of each category was (maximum possible score/4-1 ) with the score being zero in the "none" category. For example, if the maximum possible score was 32, then, none: 0, mild: 1-8, moderate: 9-16, severe: 17-24, great: 24-32.
Measured: daily for three days
The Numeric Pain Rating Scale
The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. scale is the most widely used single-dimension assessment scale.The total score is divided into 4 main categories: zero, which indicates no pain; 1-3 grades, which indicates mild pain; 4-6 grades, which indicate moderate pain; and 7-10 grades, which indicate severe pain
Measured: daily for three days
Insomnia Severity Index Scale
The Insomnia Severity Index (ISI) is a widely used self-report questionnaire designed to assess the severity of insomnia. It consists of seven questions, each rated on a scale that reflects the severity of sleep problems experienced over the last two weeks. The total score is calculated by summing the responses to all seven items, with potential scores ranging from 0 to 28.
Total Score Calculation 0-7: No clinically significant insomnia 8-14: Subthreshold insomnia 15-21: Clinical insomnia (moderate severity) 22-28: Clinical insomnia (severe)
Measured: daily for three days
Secondary outcomes (1)
ICU length
How long patient stay in ICU
Measured: an average three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Aug 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology PatientsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The Benson relaxation consisted of the following steps: (1) Sitting or lying down quietly in a comfortable position; (2) Closing eyes; (3) Deeply relaxing all muscles, beginning at the feet and progressing up to the face. Keeping them relaxed; (4) Breathing through the nose. (5) Maintaining a passive attitude and permitting relaxation to occur at its own pace; (6) Continuing for 15 minutes. When finished, sit quietly for several minutes, at first with eyes closed and later with eyes opened. Do not stand up for a few minutes. According to the agreement, the patients in both groups were required to perform the Benson relaxation technique regularly twice daily (morning and evening) for seven days in a row. Each session lasted 15 minutes.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimmaa Elsayed, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661239
- Sponsor's protocol ID
- Damanhour university
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Benson Relaxation Technique on Pain Level, Insomnia, Nausea, Vomiting, and Retching in Oncology Patients Admitted to Intensive Care Units
- ClinicalTrials.gov ID
- NCT06661239
- Acronym / sponsor ID
- Damanhour university
- Conditions
- Oncology Patients, Relaxation Program
- Keywords
- benson relaxation, Oncology/ cancer patients, Clinical outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 28 Oct 2024 (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 benson Relaxation Technique (BRT), developed by Dr. Herbert Benson, is a method aimed at reducing stress and anxiety through a series of simple steps designed to elicit the "Relaxation Response." This response is a physiological state that counteracts the harmful effects of stress, characterized by decreased heart rate, lower metabolism, and reduced breathing rate
Detailed description
The benson relaxation consisted of the following steps: (1) Sitting or lying down quietly in a comfortable position; (2) Closing eyes; (3) Deeply relaxing all muscles, beginning at the feet and progressing up to the face. Keeping them relaxed; (4) Breathing through the nose. Becoming aware of breathing. Focus on a word, phrase, a short prayer, or only breathing. (6) Continuing for 15 minutes. When finished, sit quietly for several minutes, at first with eyes closed and later with eyes opened. Do not stand up for a few minutes.
According to the agreement, the patients in both groups were required to perform the Benson relaxation technique regularly twice daily (morning and evening) for three days in a row. Each session lasted 15 minutes
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Benson relaxation consisted of the following steps: (1) Sitting or lying down quietly in a comfortable position; (2) Closing eyes; (3) Deeply relaxing all muscles, beginning at the feet and progressing up to the face. Keeping them relaxed; (4) Breathing through the nose. (5) Maintaining a passive attitude and permitting relaxation to occur at its own pace; (6) Continuing for 15 minutes. When finished, sit quietly for several minutes, at first with eyes closed and later with eyes opened. Do not stand up for a few minutes. According to the agreement, the patients in both groups were required to perform the Benson relaxation technique regularly twice daily (morning and evening) for seven days in a row. Each session lasted 15 minutes.
| Arm | Type | Receives |
|---|---|---|
| The benson group | Experimental | Behavioral: benson relaxationPatients who received the intervention |
| Control group | Placebo comparator | Behavioral: Routine care in unitPatients who receive routine care in units |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aged 18-60 years
- diagnosed with cancer
- alert and able to communicate.
Key exclusion criteria (3 listed)
- Patients who refused to participate in the study
- Patients with cognitive impairment
- Patient who unable to communicate
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 relaxationThe benson relaxation consisted of the following steps: (1) Sitting or lying down quietly in a comfortable position; (2) Closing eyes; (3) Deeply relaxing all muscles, beginning at the feet and progressing up to the face. Keeping them relaxed; (4) Breathing through the nose. (5) Maintaining a passive attitude and permitting relaxation to occur at its own pace; (6) Continuing for 15 minutes. When finished, sit quietly for several minutes, at first with eyes closed and later with eyes opened. Do not stand up for a few minutes. According to the agreement, the patients in both groups were required to perform the Benson relaxation technique regularly twice daily (morning and evening) for seven days in a row. Each session lasted 15 minutes | Behavioural | The benson group |
| Routine care in unitThe routine care include in the unit will be delivered to control group | Behavioural | Control group |
Primary outcome
The Rhodes Index of Nausea, Vomiting, and Retching
Time frame: daily for three days
It is a self-report tool designed to assess the severity and impact of nausea, vomiting, and retching on patients' 5-point categorical scales, the interval of each category was (maximum possible score/4-1 ) with the score being zero in the "none" category. For example, if the maximum possible score was 32, then, none: 0, mild: 1-8, moderate: 9-16, severe: 17-24, great: 24-32.
The Numeric Pain Rating Scale
Time frame: daily for three days
The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. scale is the most widely used single-dimension assessment scale.The total score is divided into 4 main categories: zero, which indicates no pain; 1-3 grades, which indicates mild pain; 4-6 grades, which indicate moderate pain; and 7-10 grades, which indicate severe pain
Insomnia Severity Index Scale
Time frame: daily for three days
The Insomnia Severity Index (ISI) is a widely used self-report questionnaire designed to assess the severity of insomnia. It consists of seven questions, each rated on a scale that reflects the severity of sleep problems experienced over the last two weeks. The total score is calculated by summing the responses to all seven items, with potential scores ranging from 0 to 28. Total Score Calculation 0-7: No clinically significant insomnia 8-14: Subthreshold insomnia 15-21: Clinical insomnia (moderate severity) 22-28: Clinical insomnia (severe)
1 secondary outcome
ICU length
Time frame: an average three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for Oncology Patients
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Routine care in unit in people with Oncology Patients and Relaxation Program, run by Damanhour 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rhodes Index of Nausea, Vomiting, and Retching (time frame: daily for three days). The study lists 3 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 26 Aug 2026.