Back to resultsEffectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
Primary Purpose
Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
music therapy
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Diseases
Eligibility Criteria
Inclusion Criteria:
- willing to participate in study
- alert, oriented and able to comprehend, speak and listen Hindi or English language.
Exclusion Criteria:
- altered sensorium
- hypotension
- unresponsiveness
- hearing disabilities
Sites / Locations
- Maharishi Markandeshwar University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental
control
Arm Description
music therapy was used in the study for 30 minutes
usual care was given to participant in control group
Outcomes
Primary Outcome Measures
beck anxiety inventory
minimum score was 1 and maximum score was 63
Secondary Outcome Measures
Full Information
NCT ID
NCT03220061
First Posted
July 10, 2017
Last Updated
July 14, 2017
Sponsor
Maharishi Markendeswar University (Deemed to be University)
1. Study Identification
Unique Protocol Identification Number
NCT03220061
Brief Title
Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
Official Title
Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
December 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effectiveness of music therapy on blood pressure and anxiety among patients undergoing haemodialysis
Detailed Description
Abstract Introduction:- dialysis is one of the technological innovation in medicine in which patients are being reported to face psychosocial and physiological problems such as anxiety, stress and hypertension etc. To relieve these problems, music therapy has been widely used as a non-pharmacological intervention with the aim to assess the effectiveness of music therapy on blood pressure and anxiety among haemodialysis patients.
Methods:- current study using true experimental pre-test post-test design was conducted among 60 haemodialysis patients which were randomly allocated to experimental (30) and control (30) group using simple random sampling. The data was collected through sample characteristics performa, blood pressure monitoring data sheet and beck anxiety inventory. Patients in experimental group were provided with 30 minutes of music therapy using slow and calm relaxing instrumental piano music whereas in control group only usual care was given.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
music therapy was soft and relaxing instrumental piano music which was given among haemodialysis patients for 30 minutes
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental
Arm Type
Experimental
Arm Description
music therapy was used in the study for 30 minutes
Arm Title
control
Arm Type
No Intervention
Arm Description
usual care was given to participant in control group
Intervention Type
Behavioral
Intervention Name(s)
music therapy
Primary Outcome Measure Information:
Title
beck anxiety inventory
Description
minimum score was 1 and maximum score was 63
Time Frame
10 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
willing to participate in study
alert, oriented and able to comprehend, speak and listen Hindi or English language.
Exclusion Criteria:
altered sensorium
hypotension
unresponsiveness
hearing disabilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
anu R panchal, nursing
Organizational Affiliation
maharishi markandeshwar university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maharishi Markandeshwar University
City
Ambala
State/Province
Haryana
ZIP/Postal Code
134003
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
master data sheet
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
only publication
IPD Sharing URL
http://anupanchal766@gmail.com
Learn more about this trial
Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
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