Acupuncture and Integrative Care in Gynecological Surgery
Assessing Effectiveness of Acupuncture and Integrative Care in Reducing Peri- and Intra-operative Pain and Anxiety in Patients With Gynecological Cancer: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing surgical procedures for gynecological cancer are frequently challenged by intense anxiety prior to surgery, reflecting the accompanying uncertainty regarding the diagnosis, treatment and prognosis of their illness. Following operation, pain and other quality of life-related concerns further exacerbate the emotional distress, which may itself aggravate pain and other symptoms. Clinical, controlled studied among patients with gynecological cancer undergoing chemotherapy had demonstrated effectiveness of complementary and integrative medicine (CIM) treatments for improving quality of life (QOL) and related symptoms, such as pain, gastro-intestinal concerns, fatigue, and anxiety.
The purpose of the proposed study is to explore the impact of CIM treatments (including acupuncture) on anxiety, pain, and general QOL of patients referred to gynecological oncology surgery. The investigators' working hypothesis is that an intensive CIM treatment program, provided to patients within 24 hours prior to and during surgery will reduce perioperative anxiety and pain, and will reduce the need for intra-operative and post-operative analgesia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eran Ben-Arye, MD
- Phone Number: 0528709282
- Email: eranben@netvision.net.il
Study Contact Backup
- Name: Ofer Lavi, MD
- Email: lavi_ofer@clalit.org.il
Study Locations
-
-
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Haifa, Israel, 35152
- Recruiting
- Carmel Medical Center
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Contact:
- Eran Ben-Arye, MD
- Phone Number: 972528709282
- Email: eranbe@clalit.org.il
-
Principal Investigator:
- Eran Ben-Arye
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria: Female patients age ≥ 18 years, who were referred to surgery for suspected/established gynecological-oncology cancer at the Carmel Medical Center; Patients diagnosed with class1-3 peri-operative risk according to American Society of Anesthesia.
Exclusion Criteria:Unwillingness to sign the research participation form and/or limitations in comprehending the informed consent; during pregnancy; patients with chronic pain treated with opiates within one month preceding surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Control group include participants randomly allocated to supportive care (with no added integrative care or acupuncture)
|
|
|
Experimental: Touch/relaxation
Touch/relaxation treatment (pre-operative)
|
Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture
|
|
Experimental: Acupuncture and touch/relaxation
Acupuncture (intra operative) and touch-relaxation treatment (pre-operative)
|
Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessment change
Time Frame: Change from pre- (1 hour before) to post-operative (24 hours following surgery)
|
Pain assessment on a visual analogue scale
|
Change from pre- (1 hour before) to post-operative (24 hours following surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety assessment change
Time Frame: Change from pre- (1 hour before) to post-operative (24 hours following surgery)
|
Anxiety assessment on a visual analogue scale
|
Change from pre- (1 hour before) to post-operative (24 hours following surgery)
|
|
Reduced analgesics use
Time Frame: During surgery (4-6 hours) and 24-hour post-surgery
|
Monitoring intra- and post-operative analgesia use
|
During surgery (4-6 hours) and 24-hour post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eran Ben-Arye, MD, Clalit Health Services
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMC-18-0037-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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