Acupuncture and Integrative Care in Gynecological Surgery

Sponsor

Carmel Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03560388

Collaborator

(none)

135

Enrollment

Location

Arms

53.3

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 acupunctureTwo 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 :

Jun 24, 2018

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Primary Outcome Measures

Pain assessment change [Change from pre- (1 hour before) to post-operative (24 hours following surgery)]
Pain assessment on a visual analogue scale

Secondary Outcome Measures

Anxiety assessment change [Change from pre- (1 hour before) to post-operative (24 hours following surgery)]
Anxiety assessment on a visual analogue scale
Reduced analgesics use [During surgery (4-6 hours) and 24-hour post-surgery]
Monitoring intra- and post-operative analgesia use

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.