Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407473530071 Date of Approval: 31/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of self-administered acupressure for substance use disorders: A randomised clinical trial
Official scientific title Effects of self-administered acupressure for substance use disorders: A randomised clinical trial
Brief summary describing the background and objectives of the trial Substance use disorders (SUDs) pose a significant global health challenge, particularly in South Africa, where socioeconomic factors exacerbate the issue. This study aims to investigate the effectiveness of self-administered acupressure as a complementary treatment for SUDs, focusing on patients in Gauteng province. Acupressure, a hands-on technique that stimulates acupuncture points, has shown promise in managing withdrawal symptoms and reducing cravings, yet remains under-researched in the context of SUDs. The literature review outlines the prevalence and impact of SUDs, highlighting their association with mental health disorders and the pressing need for effective treatment options. The study adopts the Health Belief Model to explore patients’ experiences with acupressure, aiming to determine its effects on depression, anxiety, and overall recovery. The aims of this study are to determine the effects of self-administered acupressure on the treatment of substance use disorders and to explore patients’ views and experiences on the use of self-administered acupressure to facilitate the treatment of substance use disorders. The objectives of this study are:  To investigate the effects of self-administered acupressure on the treatment of substance use disorders;  To explore patients’ views and experiences on the use of self-administered acupressure to facilitate the treatment of substance use disorders;
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2024
Actual trial start date
Anticipated date of last follow up 30/09/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Self administered acupressure The researcher will then introduce self-administered acupressure (Prescription 1) to participants in the Treatment Group (Prescription 1: Acupoint LI4, Acupoint PC6 and Acupoint SP6; press for two minutes on each acupoint and twice a day). 12 weeks The researcher will then introduce self-administered acupressure (Prescription 1) to participants in the Treatment Group (Prescription 1: Acupoint LI4, Acupoint PC6 and Acupoint SP6; press for two minutes on each acupoint and twice a day). Experimental Group (Standard treatment from rehabilitation centres + self-administered acupressure) Control Group 1 (Standard treatment from rehabilitation centres + sham acupressure) Control Group 2 (Standard treatment from rehabilitation centres). 20
Control Group Control Group 1 Prescription 2: 1 cun above acupoint LI4, 1 cun above acupoint PC6 and 1 cun above acupoint SP6; gentle touch for two minutes on each acupoint and twice a day 12 weeks For Control Group 1, the researcher will introduce self-administered acupressure Prescription 2 (Prescription 2: 1 cun above LI4, 1 cun above PC6 and 1 cun above SP6; gentle touch for two minutes on each acupoint and twice a day). According to Shi et al. (2006), the gentle touch of the acupoints in Prescription 2 does not result in therapeutic effects. Experimental Group (Standard treatment from rehabilitation centres + self-administered acupressure) Control Group 1 (Standard treatment from rehabilitation centres + sham acupressure) Control Group 2 (Standard treatment from rehabilitation centres). 20 Active-Treatment of Control Group
Control Group Control Group 2 Control Group 2 (Standard treatment from rehabilitation centres). 12 weeks No intervention for this group Experimental Group (Standard treatment from rehabilitation centres + self-administered acupressure) Control Group 1 (Standard treatment from rehabilitation centres + sham acupressure) Control Group 2 (Standard treatment from rehabilitation centres). 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients currently receiving treatment for substance use disorders at rehabilitation centres in Gauteng; • Individuals must be able to communicate in English; • Respondents must be capable of giving informed consent to participate in the study; and • • Respondents must be above the age of 18 and less than the age of 65. • Respondents who do not meet the inclusion criteria as specified above. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 27/08/2024 Research Ethics Committee Faculty of Health Sciences University of Johannesburg
Ethics Committee Address
Street address City Postal code Country
55 Beit St, Doornfontein, Johannesburg, 2028 johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The study's findings aim to contribute valuable insights into alternative therapies for Substance use disorders treatment, with the potential to enhance existing recovery strategies and promote access to complementary medicine in South Africa. Overall, this research seeks to address a significant gap in the literature and improve health outcomes for individuals struggling with substance use disorders. Pre-intervention, 4 weeks/during intervention, 6 weeks/during intervention, 8 weeks/during intervention, and 12 weeks/on completion of the intervention
Secondary Outcome The findings of this study may contribute to the use of complementary therapies to facilitate the treatment of substance abuse disorders. Pre-intervention, 4 weeks/during intervention, 6 weeks/during intervention, 8 weeks/during intervention, and 12 weeks/on completion of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ithemba Alcohol and Drug Van Riebeeck Road, Sterkfontein Psychiatric Hospital, Ward 10, Krugersdorp, 1739 Krugersdorp South Africa
Elim Clinic 133 Plane Rd, Spartan, Kempton Park, 1619. Johannesburg South Africa
Dr Fabian and Florence Ribeiro Treatment Centre Sick Bay and Admissions Florence Ribeiro Rehab, Zonderwater Rd, Cullinan, 1000 Pretoria South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Reseacher own research fund 55 Beit St, Doornfontein, Johannesburg, 2028 Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self R7106d John Orr Building Doornfontein Campus 55 Beit Street, Doornfonten Johannesburg South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zijing Hu zhu@uj.ac.za 0115596999 R7106d John Orr Building Doornfontein Campus 55 Beit Street, Doornfonten
City Postal code Country Position/Affiliation
Johannesburg South Africa Senior Lecturer University of Johannesburg
Role Name Email Phone Street address
Public Enquiries Zijing Hu zhu@uj.ac.za 0115596999 R7106d John Orr Building Doornfontein Campus 55 Beit Street, Doornfonten
City Postal code Country Position/Affiliation
Johannesburg South Africa Senior Lecturer University of Johannesburg
Role Name Email Phone Street address
Scientific Enquiries Zijing Hu zhu@uj.ac.za 0115596999 R7106d John Orr Building Doornfontein Campus 55 Beit Street, Doornfonten
City Postal code Country Position/Affiliation
Johannesburg South Africa Senior Lecturer University of Johnnesburg
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in acupressure. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report,Informed Consent Form Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact zhu@uj.ac.za
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information