Effectiveness of Music Therapy on Blood Pressure and Anxi... | NCT03220061

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

NCT03220061

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Status

Completed

Last Update Posted

Jul 18, 2017Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Kidney Diseases

Interventions

music therapy

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2016Actual

Primary Completion Date

Dec 12, 2016Actual

Completion Date

Dec 12, 2016Actual

First Submitted Date

Jul 10, 2017

First Submission Date that Met QC Criteria

Jul 14, 2017

First Posted Date

Jul 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2017

Last Update Posted Date

Jul 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ANU RANI PANCHAL, student, Maharishi Markendeswar University (Deemed to be University)Principal Investigator

Lead Sponsor

Maharishi Markendeswar University (Deemed to be University)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
music therapy	Behavioral		experimental

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
anu R panchal, nursing	maharishi markandeshwar university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maharishi Markandeshwar University		Ambāla	Haryana	134003	India

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

master data sheet

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

starting 6 months after publication

Access Criteria

only publication

URL

http://anupanchal766@gmail.com

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided