Kidney DiseasesNCT03220061
Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
A study testing music therapy in people with Kidney Diseases, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
Effectiveness of music therapy on blood pressure and anxiety among patients undergoing haemodialysis Read more about this study
- Who is it for?
- Ages 17 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 12 Dec 2016to 12 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 75 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- willing to participate in study
- alert, oriented and able to comprehend, speak and listen Hindi or English language.
Who cannot join
- altered sensorium
- hypotension
- unresponsiveness
- hearing disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Effectiveness of music therapy on blood pressure and anxiety among patients undergoing haemodialysis
Read the 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.
- Conditions
- Kidney Diseases
- Being tested
- music therapy
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | music therapy was used in the study for 30 minutes Receives: Behavioral: music therapy |
| control | No intervention | usual care was given to participant in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
beck anxiety inventory
minimum score was 1 and maximum score was 63
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start12 Dec 2016
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- music therapy was soft and relaxing instrumental piano music which was given among haemodialysis patients for 30 minutes
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANU RANI PANCHAL, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- anu R panchal, nursing, Principal investigator, maharishi markandeshwar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220061
- Sponsor's protocol ID
- 200197
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: master data sheet
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
- ClinicalTrials.gov ID
- NCT03220061
- Acronym / sponsor ID
- 200197
- Conditions
- Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- music therapy was soft and relaxing instrumental piano music which was given among haemodialysis patients for 30 minutes
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: music therapymusic therapy was used in the study for 30 minutes |
| control | No intervention | –usual care was given to participant in control group |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- willing to participate in study
- alert, oriented and able to comprehend, speak and listen Hindi or English language.
Key exclusion criteria (4 listed)
- altered sensorium
- hypotension
- unresponsiveness
- hearing disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music therapy | Behavioural | experimental |
Primary outcome
beck anxiety inventory
Time frame: 10 minutes
minimum score was 1 and maximum score was 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Individual participant dataSharing planned: Yes. master data sheet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
anu R panchal, nursing principal investigator
maharishi markandeshwar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy in people with Kidney Diseases, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
beck anxiety inventory (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.