NCT01941212

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

September 10, 2013

Last Update Submit

September 15, 2013

Conditions

Pain

Keywords

Music therapypaingynecological surgeries

Outcome Measures

Primary Outcomes (1)

  • Pain level following surgery

    VAS will be used for the evaluation of pain level

    48 hours following suegery

Study Arms (3)

Music therapy and Behavioral therapy

ACTIVE COMPARATOR

Music and behavioral therapy

Behavioral: Music therapy

Music only

ACTIVE COMPARATOR

Music therapy without behavioral therapy

Behavioral: Music therapy

Control

NO INTERVENTION

Patients will not listen to music neither will get music therapy

Interventions

Music therapyBEHAVIORAL

Music therapy will be given to patients 24 hours prior and for the first 48 hours after surgery

Music onlyMusic therapy and Behavioral therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women are schedule to undergo gynecological surgeries

You may not qualify if:

  • Neuropathy
  • Neurological conditions
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 34577, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lior Lowenstein, MD, MS

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

IL(1)