Acupuncture and Integrative Care in Gynecological Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-24

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Control

Control group include participants randomly allocated to supportive care (with no added integrative care or acupuncture)

Group Type NO_INTERVENTION

No interventions assigned to this group

Touch/relaxation

Touch/relaxation treatment (pre-operative)

Group Type EXPERIMENTAL

Acupuncture and touch/relaxation

Intervention Type OTHER

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

Acupuncture and touch/relaxation

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

Group Type EXPERIMENTAL

Acupuncture and touch/relaxation

Intervention Type OTHER

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

Interventions

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Acupuncture and touch/relaxation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes