How an educational video affects anxiety in patients having a tooth extraction
| ISRCTN | ISRCTN49216244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49216244 |
- Submission date
- 18/09/2025
- Registration date
- 22/09/2025
- Last edited
- 22/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental anxiety is a common emotional reaction that affects many people and can make dental treatments stressful. This study aims to explore whether watching an educational video before a dental extraction can affect the anxiety levels of patients compared to receiving only verbal instructions.
Who can participate?
Adults aged 18 years and older who are undergoing simple dental extraction at the dental clinics of Umm Al-Qura University Teaching Hospital.
What does the study involve?
Participants will be randomly assigned to either watch an educational video about the dental extraction procedure (intervention group) or receive only verbal instructions (control group). Their anxiety levels will be measured before and after the procedure using validated questionnaires.
What are the possible benefits and risks of participating?
Participation may help patients feel more informed about dental procedures. Risks are minimal and limited to potential discomfort or anxiety during the extraction, which is part of routine dental care.
Where is the study run from?
Umm Al-Qura University, Makkah (Saudi Arabia)
When is the study starting and how long is it expected to run for?
December 2024 to March 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Shahinaz Sembawa, snsimbawa@uqu.edu.sa
Contact information
Public, Scientific, Principal Investigator
Makkah
Makkah
23234
Saudi Arabia
 ORCID ID |
0000-0002-5259-6825 |
|---|---|
| Phone | +966 (0)503689088 |
| snsimbawa@uqu.edu.sa |
Public, Scientific
Makkah
Makkah
24269
Saudi Arabia
| ORCID ID |
0009-0006-0704-2010 |
|---|---|
| Phone | +966 (0)501572329 |
| s439010488@uqu.edu.sa |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Scientific title | Effect of an educational video on anxiety levels in patients undergoing simple dental extraction compared to standard verbal instructions: a randomized controlled trial |
| Study acronym | EDU-ANX-RCT |
| Study objectives | To explore the effect of educational video on the level of anxiety in patients undergoing dental extraction. |
| Ethics approval(s) |
Approved 09/12/2024, Umm Al-Qura University Faculty of Dentistry Biomedical Research Ethics Committee (Taif Road, Al-abdiyyah, Makkah, 21955, Saudi Arabia; +966 (0)125280347; cscenter@uqu.edu.sa), ref: YHGH011224 |
| Health condition(s) or problem(s) studied | Dental anxiety in patients undergoing dental extraction |
| Intervention | Intervention group: Participants in the intervention group receive an educational video demonstrating the dental extraction procedure. The video familiarizes patients with the steps of the extraction and aims to reduce anxiety associated with the procedure. Each participant watches the 1-minute video prior to the extraction. Control group: Participants in the control group receive the standard verbal instructions regarding the dental extraction procedure without access to the educational video. Randomization: Participants are assigned to one of the two groups using simple randomization. Each participant draws a paper from a set containing equal options for the control or intervention group, ensuring equal chance of placement in either group. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Dental anxiety measured using the Shortened Dental Anxiety Inventory (SDAI) and Visual Analogue Scale (VAS) at pre-intervention and post-intervention |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 09/12/2024 |
| Completion date | 12/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Adults aged 18 years or older 2. Patients undergoing simple dental extraction 3. Able to understand Arabic or English language |
| Key exclusion criteria | 1. Pediatric patients (under 18 years old) 2. Patients with visual, hearing, or mental disabilities 3. Patients unable to understand Arabic or English language 4. Patients undergoing procedures other than teeth extraction 5. Patients undergoing surgical extraction |
| Date of first enrolment | 11/12/2024 |
| Date of final enrolment | 28/02/2025 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Al-Abdiyyah
Makkah
21955
Saudi Arabia
Sponsor information
University/education
Makkah
Makkah
21955
Saudi Arabia
| Phone | +966 (0)125270000 |
|---|---|
| callcenter@uqu.edu.sa | |
| Website | https://uqu.edu.sa |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed dental journal and possible presentation at dental conferences |
| IPD sharing plan | The datasets generated and analyzed during the current study will be available from the corresponding author, Dr Shahinaz N. Sembawa (snsimbawa@uqu.edu.sa), upon reasonable request. The data will be available for 2 years after study completion. Data may be accessed by journals to which the article is submitted, Saudi governmental authorities, or researchers whose scientific purpose is deemed appropriate. All data are anonymized and will be used only for the purposes of this study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 22/09/2025 | No | No |
Additional files
Editorial Notes
18/09/2025: Study's existence confirmed by the Umm Al-Qura University Faculty of Dentistry Biomedical Research Ethics Committee.
