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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Pain assessment change
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Participant, care provider, and investigator are blind to allocation to control vs. intervention groups. Participant is also blind to the 2nd allocation to the two intervention group sub-arms.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Reduced analgesics use(During surgery (4-6 hours) and 24-hour post-surgery)
- Anxiety assessment change(Change from pre- (1 hour before) to post-operative (24 hours following surgery))
Investigators
Eran Ben-Arye
Clinical Associate Professor
Carmel Medical Center