An interventional study of Acupuncture and touch/relaxation in Quality of Life, sponsored by Carmel Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Carmel Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
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This study's planned enrollment of 135 is above the median of 75 across 1,089 interventional studies indexed under Agnosia.
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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.
Control group include participants randomly allocated to supportive care (with no added integrative care or acupuncture)
Touch/relaxation treatment (pre-operative)
Other: 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
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)
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)
Reduced analgesics use
Monitoring intra- and post-operative analgesia use
Time frame: During surgery (4-6 hours) and 24-hour post-surgery
Plan to share: Undecided
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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