- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06661239
Effect of the Benson Relaxation Technique on Clinical Outcomes of Oncology Patients Admitted to Intensive Care Units
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Damanhūr, Egypt
- Faculty of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18-60 years
- diagnosed with cancer
- alert and able to communicate.
Exclusion Criteria:
- Patients who refused to participate in the study
- Patients with cognitive impairment
- Patient who unable to communicate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The benson group
Patients who received the intervention
|
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 |
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Placebo Comparator: Control group
Patients who receive routine care in units
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The routine care include in the unit will be delivered to control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: daily for three days
|
measure heart rate per min
|
daily for three days
|
|
Blood pressure
Time Frame: daily for three days
|
measure blood pressure in mmHg
|
daily for three days
|
|
Respiratory rate
Time Frame: daily for three days
|
measure respiratory rate per min
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daily for three days
|
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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.
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daily for three days
|
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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
|
daily for three days
|
|
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) |
daily for three days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Icu length
Time Frame: an average three months
|
How long patient stay in ICU
|
an average three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Damanhour university (Faculty of pharmacy)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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