Acupuncture and Integrative Care in Gynecological Surgery

Study Overview
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Brief Summary
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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.The purpose of the proposed study is to explore the impact of complementary and integrative medicine (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.

Detailed Description
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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.

Official Title
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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

Conditions
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Quality of Life

Intervention / Treatment
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* Other: Acupuncture and touch/relaxation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two main arms of control and intervention. Intervention arm include two sub-arms of integrative treatment plus acupuncture vs. integrative treatment with no acupuncture
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group include participants randomly allocated to supportive care (with no added integrative care or acupuncture) | |
| Experimental: Touch/relaxation<br>Touch/relaxation treatment (pre-operative) | Other: Acupuncture and touch/relaxation<br>* Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture<br>|
| Experimental: Acupuncture and touch/relaxation<br>Acupuncture (intra operative) and touch-relaxation treatment (pre-operative) | Other: Acupuncture and touch/relaxation<br>* Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment change | 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 | Anxiety assessment on a visual analogue scale | Change from pre- (1 hour before) to post-operative (24 hours following surgery) | 
| Reduced analgesics use | Monitoring intra- and post-operative analgesia use | During surgery (4-6 hours) and 24-hour post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Integrative medicine, Acupuncture, Gynecological oncology, Surgery, Analgesia, Pain, Anxiety