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Acupuncture and Integrative Care in Gynecological Surgery

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ClinicalTrials.gov Identifier: NCT03560388
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Eran Ben-Arye, Carmel Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Quality of Life Other: Acupuncture and touch/relaxation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two main arms of control and intervention. Intervention arm include two sub-arms of integrative treatment plus acupuncture vs. integrative treatment with no acupuncture
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 24, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Anxiety

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients undergoing gynecologic-oncology surgery
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560388


Contacts
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Contact: Eran Ben-Arye, MD 0528709282 eranben@netvision.net.il
Contact: Ofer Lavi, MD lavi_ofer@clalit.org.il

Locations
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Israel
Carmel Medical center Recruiting
Haifa, Israel, 35152
Contact: Eran Ben-Arye, MD    972528709282 ext 0    eranbe@clalit.org.il   
Principal Investigator: Eran Ben-Arye         
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Eran Ben-Arye, MD Clalit Health Services
More Information
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Responsible Party: Eran Ben-Arye, Clinical Associate Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT03560388    
Other Study ID Numbers: CMC-18-0037-CTIL
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eran Ben-Arye, Carmel Medical Center:
Integrative medicine
Acupuncture
Gynecological oncology
Surgery
 Analgesia
Pain
Anxiety