Acupuncture and Integrative Care in Gynecological Surgery
ConditionQuality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCarmel Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture and touch/relaxation
Other interventionPre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Touch/relaxationExperimental treatment 1 intervention
Group C: Acupuncture and touch/relaxationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain assessment change
Pain assessment on a visual analogue scale
Time frame
Change from pre- (1 hour before) to post-operative (24 hours following surgery)Secondary outcomes
1
Anxiety assessment change
Anxiety assessment on a visual analogue scale
Time frame
Change from pre- (1 hour before) to post-operative (24 hours following surgery)2
Reduced analgesics use
Monitoring intra- and post-operative analgesia use
Time frame
During surgery (4-6 hours) and 24-hour post-surgerySponsors and contacts
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Source ClinicalTrials.gov