Acupuncture and Integrative Care in Gynecological Surgery

Not Applicable

Recruiting

• Conditions: Quality of Life
• Interventions: Other: Acupuncture and touch/relaxation

• Registration Number: NCT03560388
• Lead Sponsor: Carmel Medical Center

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 Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-18
• Study Start: 2018-06-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-08-20
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Touch/relaxation	Acupuncture and touch/relaxation	Touch/relaxation treatment (pre-operative)
Acupuncture and touch/relaxation	Acupuncture and touch/relaxation	Acupuncture (intra operative) and touch-relaxation treatment (pre-operative)

Primary Outcome Measures

Name	Time	Method
Pain assessment change	Change from pre- (1 hour before) to post-operative (24 hours following surgery)	Pain assessment on a visual analogue scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Carmel Medical center; 🇮🇱 Haifa, Israel