Acupuncture and Integrative Care in Gynecological Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Acupuncture and touch/relaxation
  Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture

Первичные конечные точки

• Pain assessment change [Срок оценки: Change from pre- (1 hour before) to post-operative (24 hours following surgery)]

Вторичные конечные точки (2)

• Anxiety assessment change [Срок оценки: Change from pre- (1 hour before) to post-operative (24 hours following surgery)]
• Reduced analgesics use [Срок оценки: During surgery (4-6 hours) and 24-hour post-surgery]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Израиль · 1 центр

• Carmel Medical center — Haifa

Публикации

• Segev Y, Abofol S, Samuels N, Schmidt M, Assaf W, Ben-Arye E. Postoperative pain following intraoperative acupuncture: a randomized-controlled study. BMJ Support Palliat Care. 2025 Aug 26;15(5):642-647. doi: 10.1136/spcare-2025-005485. PMID 40537176

Идентификаторы

NCT: NCT03560388 · CMC-18-0037-CTIL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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