Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis

Effectiveness of music therapy on blood pressure and anxiety among patients undergoing haemodialysis

Study Overview

• Status: Completed
• Conditions: Kidney Diseases
• Intervention / Treatment: Behavioral: music therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Ambala, Haryana, India, 134003
      • Maharishi Markandeshwar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; music therapy was used in the study for 30 minutes	Behavioral: music therapy
No Intervention: control; usual care was given to participant in control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
beck anxiety inventory	minimum score was 1 and maximum score was 63	10 minutes

Collaborators and Investigators

• Sponsor: Maharishi Markendeswar University (Deemed to be University)
• Investigators: Principal Investigator: anu R panchal, nursing, Maharishi Markandeshwar University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): December 12, 2016

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: 200197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: master data sheet
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: only publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No