AA on Drug Abusers by Nursing Students

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05877742
Collaborator
(none)
80
1
2
14
5.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: AA group
  • Other: Control group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Around the Turn: A Feasibility Cluster Randomized Controlled Trial of Using Auricular Acupressure to Abstain From Drug Abuse Through Training Nursing Students
Actual Study Start Date :
Mar 20, 2023
Anticipated Primary Completion Date :
May 20, 2024
Anticipated Study Completion Date :
May 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: AA group

AA for drug abusers.

Other: AA group
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.

Placebo Comparator: Control group

Routine seminar for drug abusers.

Other: Control group
To mimic the time and attention spent, the control group will individually receive a 5-minute seminar delivered by an RA.

Outcome Measures

Primary Outcome Measures

  1. Screening rate [at the 6-month follow-up]

    calculated as the number of abusers screened at participated clinics divided by number of abusers at participated clinics during the recruitment period.

  2. Eligibility rate [at the 6-month follow-up]

    calculated by dividing the number of abusers who are eligible by the number who are screened.

  3. Consent rate [at the 6-month follow-up]

    calculated by dividing the number of abusers who consent to join the study by the number who are eligible.

  4. Randomization rate [at the 6-month follow-up]

    calculated by dividing the number of abusers who are randomized into intervention and control groups by those who provide consent.

  5. Attendance rate [at the 6-month follow-up]

    calculated by dividing the number of abusers who complete the intervention by those who are randomized.

  6. Retention rate [at the 6-month follow-up]

    : 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.

  7. Adherence to intervention protocol [at the 6-month follow-up]

    calculated by dividing the number of abusers who follow the intervention protocol by those who are randomized.

  8. Complete rate [at the 6-month follow-up]

    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.

  9. Missing data [at the 6-month follow-up]

    calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.

  10. Adverse events [at the 6-month follow-up]

    defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study.

Secondary Outcome Measures

  1. Self-reported abstinence [at the 6-month follow-up]

    Self-reported drug abstinence at last 30 days.

  2. Abstinence with urine testing [at the 6-month follow-up]

    . Those who report no drug abuse within the past 30 days at the 6-month follow-up will be further invited for urine testing.

  3. Self-reported levels of craving [at the 6-month follow-up]

    The Chinese version of the 3-item craving scale will be used to measure abusers' self-reported levels of craving.

  4. Anxiety [at the 6-month follow-up]

    Generalized anxiety disorder-7 will be used to measure the severity of self-reported anxiety.

  5. Quality of life measures by short-Form Six-Dimension [at the 6-month follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Katherine Lam Hong Kong Hong Kong,China Hong Kong 0000

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Ka Wai Katherine Lam, School of Nursing, Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Katherine Lam, Research Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05877742
Other Study ID Numbers:
  • AA-drug abusers
First Posted:
May 26, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Katherine Lam, Research Assistant Professor, The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2023