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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01941212
Other study ID # RMB 017-13
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 10, 2013
Last updated September 15, 2013
Start date September 2013
Est. completion date September 2014

Study information

Verified date September 2013
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Women are schedule to undergo gynecological surgeries

Exclusion Criteria:

- Neuropathy

- Neurological conditions

- Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Rambam Health Care Campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain level following surgery VAS will be used for the evaluation of pain level 48 hours following suegery No
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