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临床试验/NCT06070090
NCT06070090已完成不适用

Tapping in Together: A Pilot Study on Group Acupuncture for Ketamine Experience Integration

Academy of Oriental Medicine Austin1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Experienced Integration Scale (EIS)

研究概览

简要总结

The goal of this pilot trial is to learn about using acupuncture for ketamine experience integration in adults aged 21-65 who are medically cleared for a ketamine prescription. The aim is to inform future controlled trials investigating efficacy by evaluating the success of:

  • recruitment
  • retention
  • assessment procedures
  • implementation of group acupuncture interventions performed just after a ketamine experience

Participants will be given acupuncture in a group setting after a small-group ketamine experience. The following day, participants will be asked to complete a few brief surveys about their experience.

详细描述

The study will solicit participants to enroll in a physician-supervised ketamine experience directly followed by group acupuncture administered in New York City, between October 1, 2023 and February 28, 2024. A group of 12-28 participants will be enrolled in the study and assigned a participant ID once screened by the researcher and medically approved by the prescribing physician.

Group acupuncture treatments will be conducted one hour after a group ketamine experience commences. The group acupuncture sessions will start with the researcher approaching each participant individually and asking to examine their pulse and tongue. The participants will be given an opportunity to share any information they would like to about specific issues they would like to address with acupuncture. If nothing is shared, the researcher will select treatment points based on their pulse, tongue, body palpation, and intake data. The general location of the points selected will be shared with the participant to gain their consent for treating those areas prior to needle insertion. While the acupuncture needles are retained, participants will rest with music playing. The needles will then be removed, one at a time, from each patient in order of treatment (unless a participant requests needle removal before then). After needle removal, the participants will be asked to sit up for a few minutes before exiting the treatment room. Both the licensed acupuncturist researcher and a psychotherapist will be in the treatment room throughout the 1-hour group acupuncture session.

Participants will be emailed a validated survey via a REDCap secure link before the group acupuncture session (if they had a previous ketamine experience), after their group acupuncture session as well as 3 months from the date of their group acupuncture session. Participants will also be sent optional feedback forms through REDCap after each acupuncture session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •between ages 21-65
  • •participant in a group ketamine experience between October 1, 2023 and February 28, 2024

排除标准

  • •currently pregnant or breastfeeding
  • •has a terminal illness
  • •does not pass medical clearance for ketamine prescription

研究组 & 干预措施

Treatment Group

Experimental

This is the group of participants who will receive group acupuncture after a ketamine experience.

干预措施: Acupuncture (Procedure)

结局指标

主要结局

Experienced Integration Scale (EIS)

时间窗: Three months after experience

The scale is intended to gain a sense of the status of a participant's integration process after a psychedelic experience. Participants are asked to rate their agreement to 12 statements using a five-point Likert scale with the anchors "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree." The items are worded in a positive direction, so that higher scores indicating greater integration.

Experienced Integration Scale (EIS)

时间窗: One day after experience

The scale is intended to gain a sense of the status of a participant's integration process after a psychedelic experience. Participants are asked to rate their agreement to 12 statements using a five-point Likert scale with the anchors "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree." The items are worded in a positive direction, so that higher scores indicating greater integration.

次要结局

未报告次要终点

研究者

发起方
Academy of Oriental Medicine Austin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marjorie Navarro

Licensed Acupuncturist

Academy of Oriental Medicine Austin

研究点 (1)

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