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Clinical Trials/NCT05910541
NCT05910541
Completed
Not Applicable

The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients: A Randomised Controlled Trial

University Malaysia Sarawak1 site in 1 country80 target enrollmentJanuary 2, 2020
ConditionsAdvanced Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Cancer
Sponsor
University Malaysia Sarawak
Enrollment
80
Locations
1
Primary Endpoint
Total score of ESAS
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to determine the efficacy of multisession mindful breathing in reducing symptoms among patients with advanced cancer. Adult patients with advanced cancer will be assessed using Edmonton Symptom Assessment System (ESAS) scoring system. Patients who scored ≥4 in at least two or more components in ESAS will be recruited and randomly assigned to either 4 daily-session of 30-minute mindful breathing and standard care or standard care alone.

Detailed Description

Patients with advanced cancer admitted to the medical and surgical wards of UMMC were consecutively approached to screen for eligibility. The 30-minute mindful breathing of the intervention group was guided by similar investigators for four consecutive days. These investigators were medical doctors who had been trained by the primary investigators - a palliative care physician and a certified mindfulness trainer. Each session used different scripts and was conducted in the languages that were preferred by the patients (such as Malay, English, or Mandarin). Briefly, patients were primed with knowledge of the gist of each script before being instructed to relax their bodies, close their eyes, pay attention to their breathing, and follow the guidance given. If they noticed any distractions, they were told to redirect their attention back to their breathing. Patients in the control group only received standard care and were assessed at the same time of the day by similar investigators for four consecutive days. Patients were allowed to continue their usual activities during each session.

Registry
clinicaltrials.gov
Start Date
January 2, 2020
End Date
March 31, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Malaysia Sarawak
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ongoing stage IIII-IV cancer, and a score of four or more in at least two components

Exclusion Criteria

  • impaired cognition or conscious level, as well as psychiatric illnesses that prevent them from giving informed consent or participating fully in the study

Outcomes

Primary Outcomes

Total score of ESAS

Time Frame: 30 muinutes

Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS

Secondary Outcomes

  • Individual score of the ten symptoms in ESAS(30 minutes)

Study Sites (1)

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