NCT00772226

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P50-P75 for phase_3 pain

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_3 pain

Geographic Reach
1 country

2 active sites

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

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

4 years

First QC Date

October 14, 2008

Last Update Submit

September 9, 2012

Conditions

PainPonvFatigue

Keywords

laparoscopic cholecystectomypainPONVmusictherapyfatigue after elective laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Significant reduction in post operative VAS score

    1 week

Secondary Outcomes (1)

  • Significant reduction in Stress hormone level (Cortisol and C reactive protein)

    1 day

Study Arms (2)

music

ACTIVE COMPARATOR
Device: music pillow

Pillow without music

PLACEBO COMPARATOR
Device: pillow without music

Interventions

music pillowDEVICE

according to randomisation patients will receive with/without music.

music
pillow without musicDEVICE

According to randomisation patients will receive a pillow with/without music

Pillow without music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients going for laparoscopic cholecystectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DaySurgical unit Regionshospital Randers

Randers, 8900, Denmark

Location

Regions Hospital Randers

Randers, 8900, Denmark

Location

MeSH Terms

Conditions

PainPostoperative Nausea and VomitingFatigue

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesNauseaSigns and Symptoms, DigestiveVomiting

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant M.D, Ph.D ass Proff

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 15, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

DK(2)