Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03560388

Acupuncture and Integrative Care in Gynecological Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Carmel Medical center

Haifa, 35152, Israel

Location status: Recruiting

Location contact

Eran Ben-Arye

PRINCIPAL_INVESTIGATOR

Eran Ben-Arye, MD

CONTACT

[email protected]

972528709282

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture and touch/relaxation

Other

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

Primary outcomes

  1. Pain assessment change

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

    Pain assessment on a visual analogue scale

Secondary outcomes

  1. Anxiety assessment change

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

    Anxiety assessment on a visual analogue scale

  2. Reduced analgesics use

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

    Monitoring intra- and post-operative analgesia use

Study contacts

Contact information is provided by the study sponsor or research team.

Eran Ben-Arye, MD

CONTACT

[email protected]

0528709282

Ofer Lavi, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2018
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.