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Acupuncture and Integrative Care in Gynecological Surgery

I

Israel Healthcare Foundation

Status

Enrolling

Conditions

Quality of Life

Treatments

Other: Acupuncture and touch/relaxation

Study type

Interventional

Funder types

Other

Identifiers

NCT03560388
CMC-18-0037-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

135 participants in 3 patient groups

Control
No Intervention group
Description:
Control group include participants randomly allocated to supportive care (with no added integrative care or acupuncture)
Touch/relaxation
Experimental group
Description:
Touch/relaxation treatment (pre-operative)
Treatment:
Other: Acupuncture and touch/relaxation
Acupuncture and touch/relaxation
Experimental group
Description:
Acupuncture (intra operative) and touch-relaxation treatment (pre-operative)
Treatment:
Other: Acupuncture and touch/relaxation

Trial contacts and locations

1

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Central trial contact

Ofer Lavi, MD; Eran Ben-Arye, MD

Data sourced from clinicaltrials.gov

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