Acupuncture and Integrative Care in Gynecological Surgery

NCT03560388 | Recruiting DMC

• 1 other identifier: CMC-18-0037-CTIL
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Keywords

Integrative medicine; Acupuncture; Gynecological oncology; Surgery; Analgesia; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain assessment change

  Pain assessment on a visual analogue scale

  Change from pre- (1 hour before) to post-operative (24 hours following surgery)

Secondary Outcomes (2)

• Anxiety assessment change

  Change from pre- (1 hour before) to post-operative (24 hours following surgery)

• Reduced analgesics use

  During surgery (4-6 hours) and 24-hour post-surgery

Study Arms (3)

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)

Other: Acupuncture and touch/relaxation

Acupuncture and touch/relaxation

EXPERIMENTAL

Acupuncture (intra operative) and touch-relaxation treatment (pre-operative)

Other: Acupuncture and touch/relaxation

Interventions

Acupuncture and touch/relaxation OTHER

Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture

Acupuncture and touch/relaxation; Touch/relaxation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients undergoing gynecologic-oncology surgery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical center

Haifa, 35152, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 40537176 DERIVED

MeSH Terms

Conditions

Agnosia; Pain; Anxiety Disorders

Interventions

Acupuncture Therapy; Touch

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eran Ben-Arye, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Ben-Arye, MD

CONTACT

0528709282; eranben@netvision.net.il

Ofer Lavi, MD

CONTACT

lavi_ofer@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Two main arms of control and intervention. Intervention arm include two sub-arms of integrative treatment plus acupuncture vs. integrative treatment with no acupuncture

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 18, 2018
• Study Start: June 24, 2018
• Primary Completion: August 20, 2025
• Study Completion: December 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

IL (1)