Effect of the Benson Relaxation Technique on Clinical Outcomes of Oncology Patients Admitted to Intensive Care Units

NCT06661239 | Completed DMC

• 1 other identifier: Damanhour university
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 rate, lower metabolism, and reduced breathing rate

Conditions

Oncology Patients; Relaxation Program

Keywords

benson relaxation; Oncology/ cancer patients; Clinical outcomes

Outcome Measures

Primary Outcomes (6)

• Heart rate

  measure heart rate per min

  daily for three days

• Blood pressure

  measure blood pressure in mmHg

  daily for three days

• Respiratory rate

  measure respiratory rate per min

  daily for three days

• 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.

  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

  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)

  daily for three days

Secondary Outcomes (1)

• Icu length

  an average three months

Study Arms (2)

The benson group

EXPERIMENTAL

Patients who received the intervention

Behavioral: benson relaxation

Control group

PLACEBO COMPARATOR

Patients who receive routine care in units

Behavioral: Routine care in unit

Interventions

benson relaxation BEHAVIORAL

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

The benson group

Routine care in unit BEHAVIORAL

The routine care include in the unit will be delivered to control group

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 18-60 years
• diagnosed with cancer
• alert and able to communicate.

You may not qualify if:

• Patients who refused to participate in the study
• Patients with cognitive impairment
• Patient who unable to communicate

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Faculty of Nursing

Damanhūr, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The studied patients will be masked for the intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 28, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2024-06

Locations

EG (1)