Effect of Music Therapy Intervention on Pain After Gynecological Surgery

September 15, 2013 updated by: Rambam Health Care Campus

To evaluate the effect of musical therapy before and after gynecological surgeries on pain relief following surgery.

The hypothesis is that musical therapy is effective in pain relief following surgical procedures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The intention with the study is to focus on the first postoperative phase in a case of pain upon gynecologic abdominal surgery. The literature search revealed studies reporting that participates who had pre-operative session of music intervention for relaxation experienced a greater level of reducing pain levels both pre and post their operation than in the participates in the control group. It is therefore a decision to include one pre operative session of intervention with music therapy in the design.

The study will carry out at the Gynecologic Unit, in Rambam Hospital, Israel.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 34577
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women are schedule to undergo gynecological surgeries

Exclusion Criteria:

  • Neuropathy
  • Neurological conditions
  • Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Music therapy and Behavioral therapy
Music and behavioral therapy
Behavioral: Music therapy
Music therapy will be given to patients 24 hours prior and for the first 48 hours after surgery
Active Comparator: Music only
Music therapy without behavioral therapy
Behavioral: Music therapy
Music therapy will be given to patients 24 hours prior and for the first 48 hours after surgery
No Intervention: Control
Patients will not listen to music neither will get music therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level following surgery
Time Frame: 48 hours following suegery
VAS will be used for the evaluation of pain level
48 hours following suegery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Lior Lowenstein, MD, MS, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 15, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMB 017-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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