NCT03220061

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

Same day

First QC Date

July 10, 2017

Last Update Submit

July 14, 2017

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • beck anxiety inventory

    minimum score was 1 and maximum score was 63

    10 minutes

Study Arms (2)

experimental

EXPERIMENTAL

music therapy was used in the study for 30 minutes

Behavioral: music therapy

control

NO INTERVENTION

usual care was given to participant in control group

Interventions

music therapyBEHAVIORAL
experimental

Eligibility Criteria

Age17 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • willing to participate in study
  • alert, oriented and able to comprehend, speak and listen Hindi or English language.

You may not qualify if:

  • altered sensorium
  • hypotension
  • unresponsiveness
  • hearing disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharishi Markandeshwar University

Ambāla, Haryana, 134003, India

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • anu R panchal, nursing

    maharishi markandeshwar university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: music therapy was soft and relaxing instrumental piano music which was given among haemodialysis patients for 30 minutes
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 18, 2017

Study Start

December 12, 2016

Primary Completion

December 12, 2016

Study Completion

December 12, 2016

Last Updated

July 18, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

master data sheet

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
starting 6 months after publication
Access Criteria
only publication
More information

Locations

IN(1)