Psychological predictors explaining postoperative pain after third molar surgery
| ISRCTN | ISRCTN15227371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15227371 |
| Secondary identifying numbers | B0092022000058 |
- Submission date
- 03/03/2022
- Registration date
- 08/03/2022
- Last edited
- 12/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
The aim of this study is to find out whether patients still feel a lot of pain at home after wisdom tooth extraction (postoperative pain) and whether differences in reported pain scores between patients are due to personal characteristics already present before the surgery. This study is unique because studies have so far mainly examined pain experience after wisdom tooth extraction under local anesthetic while this study focuses on the pain experienced after wisdom tooth extraction under general anesthetic.
Who can participate?
Patients aged 18 – 40 years undergoing extraction of one or more third molars (back teeth) under general anaesthesia in the ZNA Middelheim/Jan Palfijn hospital
What does the study involve?
The first survey, which will be conducted before surgery, will look at those personal characteristics that have influenced postoperative pain experiences in other studies. These characteristics are age, gender, weight and height, level of education, need for information, presence of anxious or depressed feelings and the way one deals with pain. This initial questionnaire takes about 7 minutes to complete. After the operation, participants will be requested to note both their pain score and their medication twice a day for a further 7 days. This will only take 1 to 2 minutes each time. The researchers also want to enquire about participants' functional recovery on a daily basis. This questionnaire is a little longer and takes a maximum of 5 minutes to complete.
What are the possible benefits and risks of participating?
If the researchers have sufficient results, they can anonymously analyze all the data collected and stored in a privacy-safe manner. From these results, they can subsequently draw some conclusions, which they hope to publish in a medical journal. If they can conclude from this research that the experience of pain at home after this operation is indeed still a problem, or if they find a relationship between personal characteristics, this may improve the pain experience for other patients in the future. As mentioned above, the proposed treatment and the procedures for diagnosis and follow-up correspond to good medical practice. There will be no change in the care participants receive before, during and after the procedure. They will receive the same treatment as patients who do not participate in the study. No additional risks are associated with the study.
Where is the study run from?
ZiekenhuisNetwerkAntwerpen (ZNA) Middelheim and ZNA Jan Palfijn (Belgium)
When is the study starting and how long is it expected to run for?
September 2021 to January 2023
Who is funding the study?
Ziekenhuisnetwerk Antwerpen (ZNA) (Belgium)
Who is the main contact?
Dr J. Berghmans
johan.berghmans@zna.be
Contact information
Principal Investigator
Wijerveldstraat, 69
BV Dr. J. Berghmans Anesthesist
Hasselt
3500
Belgium
 ORCID ID |
0000-0002-3835-562X |
|---|---|
| Phone | +32 (0)478496755 |
| johan.berghmans@zna.be |
Study information
| Study design | Prospective observational longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The influence of pain catastrophizing, state anxiety, need for information and depression on postoperative pain intensity and functional recovery at home after surgical third molar removal under anesthesia: a prospective observational cohort study |
| Study acronym | PPePPversion-1 |
| Study hypothesis | The hypothesis: a majority of the patients will suffer from moderate to severe pain and will experience a significant impact on functional recovery up to 7 days after surgery. Furthermore, pain catastrophizing, state anxiety, need for information and depressive thoughts will be associated with postoperative pain intensity at home and with functional recovery. |
| Ethics approval(s) | Approved 09/02/2022, Institutional Review Board - ZNA/OCMW Antwerpen (Lindendreef 1, 2020 Antwerpen Belgium; +32 (0)32803429; ethische-commissie@zna.be), ref: 009; OG 031 |
| Condition | Postoperative pain and functional recovery after ambulatory surgery for third molar extraction |
| Intervention | This is a prospective observational cohort study. Postoperative pain and functional recovery will be assessed during the first 7 days and at day 14 after ambulatory surgery for third molar extraction. Furthermore, preoperative assessment of modifiable psychological factors (like pain catastrophizing, state anxiety, need for information, depressive thought) will be evaluated. |
| Intervention type | Other |
| Primary outcome measure | 1. Postoperative pain measured using the Visual Analogue Scale – Pain (VAS-P) three times during the day of surgery (immediate postoperative, during the post-anesthesia care unit (PACU) stay and at 8 PM at home) and from day 1 up to day 7 postoperatively twice a day (at 8 AM and 8 PM) 2. Functional recovery measured using the Functional Recovery Index (FRI) once a day from day 1 up to day 7 postoperatively |
| Secondary outcome measures | 1. Pain catastrophizing measured using the Pain Catastrophizing Scale (PCS), preoperative at the day of the intervention 2. State anxiety measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), preoperative at the day of the intervention 3. Need for information measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), preoperative at the day of the intervention preoperatively 4. Depressive thoughts measured using the Hospital Anxiety and Depression Scale (HADS), preoperative at the day of the intervention |
| Overall study start date | 01/09/2021 |
| Overall study end date | 31/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 145 |
| Total final enrolment | 144 |
| Participant inclusion criteria | 1. Patients aged 18 – 40 years undergoing extraction of one or more third molars under general anaesthesia in the ZNA Middelheim/Jan Palfijn hospital 2. American Society of Anesthesiologists physical status (ASA I-II) 3. A good understanding of the Dutch language 4. Written informed consent 5. Without premedication |
| Participant exclusion criteria | 1. Refusal to participate 2. Patients with a known development delay and intellectual disability 3. Intolerance for local anesthetics and non-steroidal anti-inflammatory drugs (NSAIDs) 4. Chronic use of opioids |
| Recruitment start date | 15/03/2022 |
| Recruitment end date | 24/01/2023 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Lindendreef 1
Antwerpen
2020
Belgium
Merksem
2170
Belgium
Sponsor information
Hospital/treatment centre
Lindendreef 1
Antwerpen
2020
Belgium
| Phone | +32 (0)32803993 |
|---|---|
| stefaan.goossens@zna.be | |
| Website | https://www.zna.be |
"ROR" |
https://ror.org/05dpzfc16 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Plaaned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 24/01/2022 | 07/03/2022 | No | No |
Additional files
Editorial Notes
12/05/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 15/05/2023 to 24/01/2023.
2. The overall study end date was changed from 01/06/2023 to 31/01/2023.
3. Total final enrolment added.
07/03/2022: Trial's existence confirmed by the Institutional Review Board - ZNA/OCMW Antwerpen.
