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AA on Drug Abusers by Nursing Students

Primary Purpose

Drug Abuse

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
AA group
Control group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring Auricular Acupressure, Nursing Students

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 or above Have reported to abuse drugs within the past 30 days Can communicate in Cantonese and read Chinese Exclusion Criteria: Unstable mental conditions that are not suitable for the intervention Receiving acupuncture or acupressure treatment currently or in the previous 30 days

Sites / Locations

  • Katherine LamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AA group

Control group

Arm Description

AA for drug abusers.

Routine seminar for drug abusers.

Outcomes

Primary Outcome Measures

Screening rate
calculated as the number of abusers screened at participated clinics divided by number of abusers at participated clinics during the recruitment period.
Eligibility rate
calculated by dividing the number of abusers who are eligible by the number who are screened.
Consent rate
calculated by dividing the number of abusers who consent to join the study by the number who are eligible.
Randomization rate
calculated by dividing the number of abusers who are randomized into intervention and control groups by those who provide consent.
Attendance rate
calculated by dividing the number of abusers who complete the intervention by those who are randomized.
Retention rate
: calculated by dividing the number of abusers who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Adherence to intervention protocol
calculated by dividing the number of abusers who follow the intervention protocol by those who are randomized.
Complete rate
calculated by dividing the number of abusers who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
Missing data
calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Adverse events
defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study.

Secondary Outcome Measures

Self-reported abstinence
Self-reported drug abstinence at last 30 days.
Abstinence with urine testing
. Those who report no drug abuse within the past 30 days at the 6-month follow-up will be further invited for urine testing.
Self-reported levels of craving
The Chinese version of the 3-item craving scale will be used to measure abusers' self-reported levels of craving.
Anxiety
Generalized anxiety disorder-7 will be used to measure the severity of self-reported anxiety.
Quality of life measures by short-Form Six-Dimension
Short-Form Six-Dimension will be used to assess abusers' quality of life.It contains six dimensions of health. The Chinese version is well validated in Hong Kong.

Full Information

First Posted
May 16, 2023
Last Updated
May 25, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05877742
Brief Title
AA on Drug Abusers by Nursing Students
Official Title
Around the Turn: A Feasibility Cluster Randomized Controlled Trial of Using Auricular Acupressure to Abstain From Drug Abuse Through Training Nursing Students
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
May 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Drug abuse is a serious public health issue. Despite the serious consequences of drug abuse, there are around 2000 new cases reported by drug abusers each year. There is growing evidence of the use of auricular acupressure (AA), a traditional Chinese medicine (TCM) treatment modality, in reducing withdrawal symptoms among drug abusers. This study aims to investigate the feasibility and effectiveness of training nursing students to deliver brief education on AA on drug abusers.
Detailed Description
A 2-arm feasibility cluster RCT will be conducted in the 80 drug abusers from 7 substance abuse clinics in Hong Kong Hospital Authority following the CONSORT statement. The intervention group will receive AA intervention individually from trained nursing students. The control group will individually receive a 5-minute seminar delivered by a research assistant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
Auricular Acupressure, Nursing Students

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AA group
Arm Type
Experimental
Arm Description
AA for drug abusers.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Routine seminar for drug abusers.
Intervention Type
Other
Intervention Name(s)
AA group
Intervention Description
Participants will individually receive a 5-minute AA education delivered verbally at his/her respective clinic by a trained nursing student interventionist in addition to the usual scheduled follow-ups and activities at clinics.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
To mimic the time and attention spent, the control group will individually receive a 5-minute seminar delivered by an RA.
Primary Outcome Measure Information:
Title
Screening rate
Description
calculated as the number of abusers screened at participated clinics divided by number of abusers at participated clinics during the recruitment period.
Time Frame
at the 6-month follow-up
Title
Eligibility rate
Description
calculated by dividing the number of abusers who are eligible by the number who are screened.
Time Frame
at the 6-month follow-up
Title
Consent rate
Description
calculated by dividing the number of abusers who consent to join the study by the number who are eligible.
Time Frame
at the 6-month follow-up
Title
Randomization rate
Description
calculated by dividing the number of abusers who are randomized into intervention and control groups by those who provide consent.
Time Frame
at the 6-month follow-up
Title
Attendance rate
Description
calculated by dividing the number of abusers who complete the intervention by those who are randomized.
Time Frame
at the 6-month follow-up
Title
Retention rate
Description
: calculated by dividing the number of abusers who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Time Frame
at the 6-month follow-up
Title
Adherence to intervention protocol
Description
calculated by dividing the number of abusers who follow the intervention protocol by those who are randomized.
Time Frame
at the 6-month follow-up
Title
Complete rate
Description
calculated by dividing the number of abusers who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
Time Frame
at the 6-month follow-up
Title
Missing data
Description
calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Time Frame
at the 6-month follow-up
Title
Adverse events
Description
defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study.
Time Frame
at the 6-month follow-up
Secondary Outcome Measure Information:
Title
Self-reported abstinence
Description
Self-reported drug abstinence at last 30 days.
Time Frame
at the 6-month follow-up
Title
Abstinence with urine testing
Description
. Those who report no drug abuse within the past 30 days at the 6-month follow-up will be further invited for urine testing.
Time Frame
at the 6-month follow-up
Title
Self-reported levels of craving
Description
The Chinese version of the 3-item craving scale will be used to measure abusers' self-reported levels of craving.
Time Frame
at the 6-month follow-up
Title
Anxiety
Description
Generalized anxiety disorder-7 will be used to measure the severity of self-reported anxiety.
Time Frame
at the 6-month follow-up
Title
Quality of life measures by short-Form Six-Dimension
Description
Short-Form Six-Dimension will be used to assess abusers' quality of life.It contains six dimensions of health. The Chinese version is well validated in Hong Kong.
Time Frame
at the 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 or above Have reported to abuse drugs within the past 30 days Can communicate in Cantonese and read Chinese Exclusion Criteria: Unstable mental conditions that are not suitable for the intervention Receiving acupuncture or acupressure treatment currently or in the previous 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Wai Katherine Lam
Phone
27666420
Email
kw-katherine.lam@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Yan Ho
Phone
2766417
Email
kyeva.ho@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Wai Katherine Lam
Organizational Affiliation
School of Nursing, Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katherine Lam
City
Hong Kong
State/Province
Hong Kong,China
ZIP/Postal Code
0000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Lam, Phd

12. IPD Sharing Statement

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AA on Drug Abusers by Nursing Students

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