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Study Summary
No. 2007-0600:.......Gynecology......Grace C. Chi......Nursing
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Study Summary Title
Study Summary
Number:
2007-0600
Study Title:Music Relaxation Video and Pain Control: A Randomized Controlled Trial for Women Receiving Intracavitary Brachytherapy for Gynecological Cancer
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Physician New Patient Referral
Name:Grace C. ChiPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:NursingReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2425
Contact us about clinical trials
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General Information
Disease Group:GynecologySupported By:Texas Woman's University, College of Nursing, Houston Center
Phase of Study:N/AReturn
Visit:
N/A
Treatment
Agents:
Music Relaxation VideoHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
The length of stay for inpatient brachytherapy treatment is 48 hours to 72
hours.
Description/
Intervention:
The goal of this study is to learn if viewing a music relaxation video helps
patients to feel less pain when they have intracavitary brachytherapy
treatment.
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Study Objectives / Outcomes
The primary objective of this study is to examine the effects of a non-pharmacological intervention, using audio-visual music relaxation video on pain severity, as measured by a visual rating scale, for patients receiving intracavitary brachytherapy. In addition, opioid consumption of patient-controlled analgesia (PCA), the demanded injections and delivered injections of the PCA, and anxiety will be measured. Experimental group participants will view a 30-minute music relaxation video for a total of four times during the first 44 hours of the brachytherapy treatment period. Thus, the pain scores of severity, opioid consumption of PCA, demanded injections and delivered injections of PCA and anxiety for the experimental and control groups will be compared.

The issue of pain management has demanded increased attention and concern of health professionals. Nursing research has the potential to improve quality of nursing care and pain control of patients. The findings will add new information to the existing nursing knowledge for use in future nursing practice. The proposed intervention is low-cost, has minimal risk of harmful side-effects, is relatively simple to deliver, and is noninvasive. The intervention provides a viable option that can offer patients additional comfort in a stressful situation and has the potential to enhance nursing knowledge and practice.

Hypotheses:

Five hypotheses are listed below in a concise method:

1. & 2. Females ages 18 and older, who receive intracavitary brachytherapy for gynecologic cancer at a cancer treatment center and who participate in viewing a 30-minute music relaxation video for a total of four times during the first 44 hours of the brachytherapy treatment period, will have lower pain scores and less opioid consumption of PCA, as compared to females who receive intracavitary brachytherapy for gynecologic cancer at a cancer treatment center and do not receive the music relaxation video.

3. & 4. Females ages 18 and older, who receive intracavitary brachytherapy for gynecologic cancer at a cancer treatment center and who participate in viewing a 30-minute music relaxation video for a total of four times during the first 44 hours of the brachytherapy treatment period, will have fewer demanded injections and delivered injections of patient-controlled analgesia (PCA) recorded, as compared to females who receive intracavitary brachytherapy for gynecologic cancer at a cancer treatment center and do not receive the music relaxation video.
    5. Females ages 18 and older, who receive intracavitary brachytherapy for gynecologic cancer at a cancer treatment center and who participate in viewing a 30-minute music relaxation video for a total of four times during the first 44 hours of the brachytherapy treatment period, will have lower anxiety scores, as compared to females who receive intracavitary brachytherapy for gynecologic cancer at a cancer treatment center and do not receive the music relaxation video.
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    Study Status Information
    Study Activation / Registration Date:03/25/2008
    IRB Review and Approval Date:03/25/2008
    Study Type:Other
    Recruitment Status:Open
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

    Inclusion Criteria:1) Female patients 18 years of age and older diagnosed with cervical cancer in the disease stage Ia2, Ib, Ib1, Ib2, II, IIa, IIb, IIIa, IIIb or IVa based on International Federation of Gynecology and Obstetrics (FIGO) classification and receiving the first intracavitary pulsed-dose-rate (PDR) brachytherapy requiring at least 44 hours of therapy,

    2) ability to read English,

    3) comprehend and follow oral and written instruction,

    4) ability to view and listen to 30-minute music relaxation video,

    5) receiving IV PCA pain management per analgesia orders,

    6) no documented evidence of any hearing or vision deficit,

    7) a score within Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2, indicating a capability for ambulatory and self care, will be included.

    Exclusion Criteria:1) Male patients will be excluded.

    2) Manual afterload or Selectron treatments will be excluded.

    3) Receiving epidural per analgesia orders will be excluded.

    4) Absolute neutrophil count (ANC) count is less than 1000/mm3 from the most recent blood count lab report prior to the time of enrollment will be excluded.

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    Links
    Registration Number: Not Applicable Clinical Trial

    Other Links:
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