The Use of Music as Pain Therapy in Patients Undergoing L... | NCT00772226

Studies
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit

NCT00772226

Sponsor

Randers Regional Hospital

Status

Completed

Last Update Posted

Sep 11, 2012Estimated

Enrollment

204Actual

Phase

Phase 3

Conditions

Pain
Ponv
Fatigue

Interventions

music pillow
pillow without music

Countries

Denmark

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

Sep 2012

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

Sep 2008

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Oct 14, 2008

First Submission Date that Met QC Criteria

Oct 14, 2008

First Posted Date

Oct 15, 2008Estimated

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

Sep 9, 2012

Last Update Posted Date

Sep 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thorbjorn Sommer, Consultant M.D, Ph.D ass Proff, Randers Regional HospitalPrincipal Investigator

Lead Sponsor

Randers Regional HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of stress as measured by Cortisol and C reactive protein.

Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1 and 7 post-OP.

Detailed Description

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

204Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
music	Active Comparator		Device: music pillow
Pillow without music	Placebo Comparator		Device: pillow without music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
music pillow	Device	according to randomisation patients will receive with/without music.	music

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Significant reduction in post operative VAS score		1 week

Secondary Outcomes

Measure	Description	Time Frame
Significant reduction in Stress hormone level (Cortisol and C reactive protein)		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients going for laparoscopic cholecystectomy

Exclusion Criteria:

Age below 18,
Use of NSAID, morphine, steroids
Disability
Previous surgery in the past month
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DaySurgical unit Regionshospital Randers		Randers		8900	Denmark
Regions Hospital Randers

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D020250	Postoperative Nausea and Vomiting
D005221	Fatigue

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided