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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control group include participants randomly allocated to supportive care (with no added integrative care or acupuncture) | |
| Touch/relaxation | Experimental | Touch/relaxation treatment (pre-operative) |
|
| Acupuncture and touch/relaxation | Experimental | Acupuncture (intra operative) and touch-relaxation treatment (pre-operative) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture and touch/relaxation | Other | Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture |
|
| 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) |
| 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 |
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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.
Patients undergoing gynecologic-oncology surgery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eran Ben-Arye, MD | Contact | 0528709282 | eranben@netvision.net.il | |
| Ofer Lavi, MD | Contact | lavi_ofer@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Eran Ben-Arye, MD | Clalit Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmel Medical center | Recruiting | Haifa | 35152 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40537176 | Derived | Segev Y, Abofol S, Samuels N, Schmidt M, Assaf W, Ben-Arye E. Postoperative pain following intraoperative acupuncture: a randomized-controlled study. BMJ Support Palliat Care. 2025 Aug 26;15(5):642-647. doi: 10.1136/spcare-2025-005485. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D014110 | Touch |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
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Two main arms of control and intervention. Intervention arm include two sub-arms of integrative treatment plus acupuncture vs. integrative treatment with no acupuncture
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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.
| During surgery (4-6 hours) and 24-hour post-surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |