Acupuncture and Integrative Care in Gynecological Surgery

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03560388
• Other study ID #: CMC-18-0037-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2023
• Source: Carmel Medical Center
• Contact: Eran Ben-Arye, MD
• Phone: 0528709282
• Email: eranben[@]netvision.net.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Other:
• Acupuncture and touch/relaxation
Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture

Locations

Country	Name	City	State
Israel	Carmel Medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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