PainNCT04643951
Pain in Pediatric Dentistry - a Grounded Theory Study on the Experiences of Dental Professionals and Students
An observational study of Pain, run by Malmö University at 1 site in Sweden.
Trial summary
This is a qualitative interview study, using Grounded Theory. The aim is to deepen our knowledge about how the dental team (dentists, dental hygienists, and dental assistants) and dental students perceive child patients' pain and how they perceive they are equipped to prevent and deal with child patients' pain and the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2020to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 4th and 5th year dental students, and dental professionals (dentists, dental hygienists, dental assistants)
Who may be able to join
- Dental students in their 4th or 5th year of training
- Dental professionals working with child patients on a regular basis
Who cannot join
- Do not understand Swedish language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Malmö University
Malmö, Skåne County, 205 06
Rikard Roxner, MScDSc, +46 40 665 84 80, rikard.roxnmer@gmail.com
About this study
Official title: Pain in Pediatric Dentistry - a Grounded Theory Study on the Experiences of Dental
This is a qualitative interview study, using Grounded Theory. The aim is to deepen our knowledge about how the dental team (dentists, dental hygienists, and dental assistants) and dental students perceive child patients' pain and how they perceive they are equipped to prevent and deal with child patients' pain and the child's response to pain during and after dental treatment.
Read the detailed description
BACKGROUND Pain in conjunction with dental treatment should be avoided, especially when treating children. Many dental procedures may result in procedural and/or postoperative pain. There is a well-documented relationship between perceived pain during dental treatment, and the development of dental fear and anxiety. This may lead to suffering for the patient, avoidance of dental care, and increasing treatment costs for the individual and society. Dental care professionals are responsible for providing as painless dental treatments as possible to their child patients. Earlier studies have pointed towards an underusage of local anesthetics when providing dental care to children. Though previous studies have not been able to fully answer why this is. Thus, the aim of this study is to gain knowledge into how dental professionals and students experience and relate to the child patient's experience of pain during and after dental treatment.
METHOD This is a qualitative study using Grounded Theory (GT). Dental students in their last two years of education and dental professionals (dentists, dental hygienists, and dental assistants), will be consecutively enrolled after signing an informed consent form.
In-depth interviews of approximately one hour each will be performed with the informants at a place of their convenience. Appropriate measures will be taken regarding public health recommendations in effect due to the Covid-19 pandemic.
In GT no sample size calculation is done. Participants will be included until saturation in data is reached, i.e. no new information can be obtained from further interviews. In GT this is often achieved after 10-15 interviews, but due to the scope of this study involving several different professionals and students it is likely the number of informants will be closer to 25. All interviews will be tape recorded, and without delay, the interviews will be transcribed verbatim. Data analyses and data collection will be done in tandem. The transcribed interviews will be analyzed, and codes identified. These codes will then be merged into different preliminary categories. In the following axial coding process, each category will be further developed by identifying common dimensions and characteristics (subcategories). Relations between data and categories is sought, and hereby a new whole is created. Selective coding will lead to data saturation and validation. Saturation can also be achieved by already retrieved data being re-coded.
KNOWLEDGE GAINS GT is a theory generating method. This is especially suitable for research areas where theories are scarce or lacking. A lot of research within the medical and dental field today, takes the perspective of the investigator, and far too seldom is the subjective experience of those directly affected (e.g. professionals and/or patients) heard. From this study we will gain new knowledge into dental professionals' and students' perception of the child patients' experiences of procedural and postoperative pain. These knowledge gains will be important for future research strategies related to pain. In the longer run the results can help lead to a better training of undergraduate students and professionals.
CHANGES TO ORIGINAL STUDY PLAN After the initial interviews were made, we saw that dental students had a pedagogical focus in their interviews. Therefore, we decided to split informants into two groups - dental students and dental professionals. Findings will be presented in two separate scientific papers, one for each group of participants. Interviews with dental students have been completed, while interviews with dental professionals are ongoing.
- Conditions
- Pain
- Being tested
- Interview
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Interview study using Grounded theory, to investigate dental professionals' and students' perception of child patient's experience and need for treatment regarding procedural and postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Dental students | Dental students in their two final years. No intervention. Receives: Behavioral: Interview | |
| Dental professionals | Dental professionals aged 18-65, regularly working with children. No intervention. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in pediatric dentistry, a Grounded theory study on the experiences of dental professionals and students.
By means of in-depth interviews and data analysis according to Grounded Theory, investigate dental professionals' and dental students' perceptions of child patients' experiences of pain related to dental treatment.
Measured: June, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikard Roxner, Malmö University
- Investigators
- Gunilla Klingberg, Prof., Study chair, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643951
- Sponsor's protocol ID
- FO 2020/529.
- Status last verified
- May 2025
- First submitted
- 9 Nov 2020
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berlin H, List T, Ridell K, Klingberg G. Dentists' attitudes towards acute pharmacological pain management in children and adolescents. Int J Paediatr Dent. 2018 Mar;28(2):152-160. doi: 10.1111/ipd.12316. Epub 2017 Jul 10.
PubMed 28691744Murtomaa H, Milgrom P, Weinstein P, Vuopio T. Dentists' perceptions and management of pain experienced by children during treatment: a survey of groups of dentists in the USA and Finland. Int J Paediatr Dent. 1996 Mar;6(1):25-30. doi: 10.1111/j.1365-263x.1996.tb00204.x.
PubMed 8695586Rasmussen JK, Frederiksen JA, Hallonsten AL, Poulsen S. Danish dentists' knowledge, attitudes and management of procedural dental pain in children: association with demographic characteristics, structural factors, perceived stress during the administration of local analgesia and their tolerance towards pain. Int J Paediatr Dent. 2005 May;15(3):159-68. doi: 10.1111/j.1365-263X.2005.00635.x.
PubMed 15854111Charmaz, K. Grounded theory. In: Smith, J.A., Harre, R. & van Langenhove, L. (eds.) Rethinking methods in psychology. 2nd ed. London: Sage Publications, 1995; 27-49.
Glaser, B. & Strauss, A. The discovery of grounded theory: strategies for qualitative research. New York: Aldine de Gruyter, 1967.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain in Pediatric Dentistry - a Grounded Theory Study on the Experiences of Dental
- ClinicalTrials.gov ID
- NCT04643951
- Acronym / sponsor ID
- FO 2020/529.
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a qualitative interview study, using Grounded Theory. The aim is to deepen our knowledge about how the dental team (dentists, dental hygienists, and dental assistants) and dental students perceive child patients' pain and how they perceive they are equipped to prevent and deal with child patients' pain and the child's response to pain during and after dental treatment.
Detailed description
BACKGROUND Pain in conjunction with dental treatment should be avoided, especially when treating children. Many dental procedures may result in procedural and/or postoperative pain. There is a well-documented relationship between perceived pain during dental treatment, and the development of dental fear and anxiety. This may lead to suffering for the patient, avoidance of dental care, and increasing treatment costs for the individual and society. Dental care professionals are responsible for providing as painless dental treatments as possible to their child patients. Earlier studies have pointed towards an underusage of local anesthetics when providing dental care to children. Though previous studies have not been able to fully answer why this is. Thus, the aim of this study is to gain knowledge into how dental professionals and students experience and relate to the child patient's experience of pain during and after dental treatment.
METHOD This is a qualitative study using Grounded Theory (GT). Dental students in their last two years of education and dental professionals (dentists, dental hygienists, and dental assistants), will be consecutively enrolled after signing an informed consent form.
In-depth interviews of approximately one hour each will be performed with the informants at a place of their convenience. Appropriate measures will be taken regarding public health recommendations in effect due to the Covid-19 pandemic.
In GT no sample size calculation is done. Participants will be included until saturation in data is reached, i.e. no new information can be obtained from further interviews. In GT this is often achieved after 10-15 interviews, but due to the scope of this study involving several different professionals and students it is likely the number of informants will be closer to 25. All interviews will be tape recorded, and without delay, the interviews will be transcribed verbatim. Data analyses and data collection will be done in tandem. The transcribed interviews will be analyzed, and codes identified. These codes will then be merged into different preliminary categories. In the following axial coding process, each category will be further developed by identifying common dimensions and characteristics (subcategories). Relations between data and categories is sought, and hereby a new whole is created. Selective coding will lead to data saturation and validation. Saturation can also be achieved by already retrieved data being re-coded.
KNOWLEDGE GAINS GT is a theory generating method. This is especially suitable for research areas where theories are scarce or lacking. A lot of research within the medical and dental field today, takes the perspective of the investigator, and far too seldom is the subjective experience of those directly affected (e.g. professionals and/or patients) heard. From this study we will gain new knowledge into dental professionals' and students' perception of the child patients' experiences of procedural and postoperative pain. These knowledge gains will be important for future research strategies related to pain. In the longer run the results can help lead to a better training of undergraduate students and professionals.
CHANGES TO ORIGINAL STUDY PLAN After the initial interviews were made, we saw that dental students had a pedagogical focus in their interviews. Therefore, we decided to split informants into two groups - dental students and dental professionals. Findings will be presented in two separate scientific papers, one for each group of participants. Interviews with dental students have been completed, while interviews with dental professionals are ongoing.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental students | – | Behavioral: InterviewDental students in their two final years. No intervention. |
| Dental professionals | – | Behavioral: InterviewDental professionals aged 18-65, regularly working with children. No intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 4th and 5th year dental students, and dental professionals (dentists, dental hygienists, dental assistants)
Key inclusion criteria (2 listed)
- Dental students in their 4th or 5th year of training
- Dental professionals working with child patients on a regular basis
Key exclusion criteria (1 listed)
- Do not understand Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewInterview study using Grounded theory, to investigate dental professionals' and students' perception of child patient's experience and need for treatment regarding procedural and postoperative pain. | Behavioural | Dental professionals, Dental students |
Primary outcome
Pain in pediatric dentistry, a Grounded theory study on the experiences of dental professionals and students.
Time frame: June, 2021
By means of in-depth interviews and data analysis according to Grounded Theory, investigate dental professionals' and dental students' perceptions of child patients' experiences of pain related to dental treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 28691744Berlin H, List T, Ridell K, Klingberg G. Dentists' attitudes towards acute pharmacological pain management in children and adolescents. Int J Paediatr Dent. 2018 Mar;28(2):152-160. doi: 10.1111/ipd.12316. Epub 2017 Jul 10.
- Background: PubMed 8695586Murtomaa H, Milgrom P, Weinstein P, Vuopio T. Dentists' perceptions and management of pain experienced by children during treatment: a survey of groups of dentists in the USA and Finland. Int J Paediatr Dent. 1996 Mar;6(1):25-30. doi: 10.1111/j.1365-263x.1996.tb00204.x.
- Background: PubMed 15854111Rasmussen JK, Frederiksen JA, Hallonsten AL, Poulsen S. Danish dentists' knowledge, attitudes and management of procedural dental pain in children: association with demographic characteristics, structural factors, perceived stress during the administration of local analgesia and their tolerance towards pain. Int J Paediatr Dent. 2005 May;15(3):159-68. doi: 10.1111/j.1365-263X.2005.00635.x.
- BackgroundCharmaz, K. Grounded theory. In: Smith, J.A., Harre, R. & van Langenhove, L. (eds.) Rethinking methods in psychology. 2nd ed. London: Sage Publications, 1995; 27-49.
- BackgroundGlaser, B. & Strauss, A. The discovery of grounded theory: strategies for qualitative research. New York: Aldine de Gruyter, 1967.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gunilla Klingberg, Prof. study chair
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rikard Roxner, DDS (+46 40 665 84 80, rikard.roxner@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in pediatric dentistry, a Grounded theory study on the experiences of dental professionals and students. (time frame: June, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04643951, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.