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CompletedNCT04064853Updated Mar 15, 2023

Childrens' Experiences of Pain in Conjunction With Tooth Extraction - a Grounded Theory Study

An observational study in Attitude, Pain, Postoperative and Pain, Procedural, sponsored by Malmö University. Completed at 1 site in Sweden. Open to participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Malmö University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
12
Ages
10 Years to 15 Years
Sex
All
01

Study summary

This is a qualitative study, using Grounded Theory. The aim is to deepen our knowledge about how children perceive pain in conjunction with dental treatment; tooth extractions in particular. What increases, and what decreases, the risk of children experiencing pain; and how do they perceive dental treatments where pain might occur, either as procedural pain, or postoperatively?

Read the detailed description

BACKGROUND: Pain in conjunction with dental treatment should be avoided as much as possible, when treating children. Many dental procedures may result in procedural and/or postoperative pain. There is a well-documented relationship between perceived pain during/after dental treatment, and the development of dental fear and anxiety. This may lead to suffering for the patient and accelerating treatment-costs for society. Despite this, research on children and pain is scarce. Systematic review shows a lack of studies on oral analgesics and their possibility to reduce/prevent pain. There is a need for randomized clinical trials regarding different treatments and effect of analgesics. However, before such research can be undertaken, one important piece is missing; an understanding on how children and adolescents perceive dental treatment and the possible pain afterwards. The aim of this study is to elucidate how children perceive dental treatment and pain after tooth extractions.

METHODS: This is a qualitative study using Grounded Theory (GT). Children aged 10-15 years, who needs teeth extracted prior orthodontic treatment, will be consecutively enrolled if the legal guardians signs the informed consent-form and the child assents to participate. Tooth extractions will then be performed by another dentist than the one doing the interviews with the children. A treatment protocol, in accordance with today standardized practice, for the extractions will be followed. No extra dental treatment is performed, rather this is a part of the whole treatment plan for orthodontic treatment. In-depth interview will be performed with the children 1-2 weeks after tooth extraction, at a place convenient for the child/family. If the participant wishes to, they can be accompanied by their legal guardian during the interview. The questions will focus on their experiences of the tooth extraction, perceived pain, pain management, coping strategies, and previous experiences of pain and how they handled it then. Each interview is calculated to take approximately one hour. In Grounded Theory no sample size calculation is applicable. Participants will be included until saturation in data is reached, i.e. no new information can be obtained. In GT this is often achieved after 10-15 interviews, but when it involves children it is not unlikely that the number of participants will be closer to 20, since there is a risk of the interviews not being so "rich". All interviews will be tape recorded, and without further delay, the interviews will be transcribed. Data analyses and data collection will be done parallel with each other. The transcribed interviews will be analyzed, where codes will be identified. These codes will then merge into different preliminary categories. In the following axial coding process, each category will be further developed by identifying dimensions and characteristics (sub-categories). Relations between data and categories is sought for, 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 completely lacking. A lot of research within the medical and dental field today, takes the perspective of the investigator, and far too seldom is those directly affected (i.e. the patient), involved. From an ethical point of view, it is important to include children and adolescents if the research is targeting this group. If knowledge about how children and adolescents perceive pain is gained, this will be an important piece in assembling the puzzle of research strategies related to pain.

02

Conditions studied

  • Attitude
  • Pain, Postoperative
  • Pain, Procedural
  • Child
  • Adolescent
  • Tooth Extraction

Keywords

  • grounded theory
  • child
  • adolescent
  • postoperative pain
  • procedural pain
  • tooth extraction
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 12 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Malmö University is the lead sponsor of 42 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children aged 10-15 years of age, identified as eligable according to inclusion and exclusion criteria, during first visit to orthodontist, working in city of Malmö, Sweden.

Inclusion criteria

  • Healthy individuals
  • In need of extraction of permanent premolars prior orthodontic treatment

Exclusion criteria

Exclusion Criteria:

  • If sedation is needed to be able to comply with dental treatment
  • Do not understand Swedish language
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
12 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Children's experiences during and after tooth extraction, and it's consequences

    After tooth extraction, on orthodontic indications, participants, 10-15 years of age, are interviewed. The interviews are transcribed and analyzed, identifying codes, which will be clustered into categories. Through different types of methods, used in Grounded Theory, core categories will be identified which together with other categories and sub-categories, will answer the question "what is all this about?".

    Time frame: Fall 2019

07

Study locations

1 site
  • Faculty of Odontology, Malmö University
    Malmö, Scania SE-20506, Sweden
08

References and documents

Publications

  • Berlin H, List T, Ridell K, Davidson T, Toft D, Klingberg G. Postoperative pain profile in 10-15-year-olds after bilateral extraction of maxillary premolars. Eur Arch Paediatr Dent. 2019 Dec;20(6):545-555. doi: 10.1007/s40368-019-00425-9. Epub 2019 Apr 8. PubMed 30963511 ↗
  • 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 28691744 ↗
  • Charmaz K. Grounded theory. In: Smith JA, Harre R, van Langenhove L, eds. Rethinking methods in psychology, 2nd ed. London: Sage Publications, 1995; 27-49.
  • Charmaz K. Grounded theory. Objectivist and constructivist methods. In: Denzin NK, Lincoln YS, eds. Handbook of qualitative research, 2nd ed. Thousand Oaks, CA: Sage, 2000; 509-535.
  • Dellve L, Henning Abrahamsson K, Trulsson U, Hallberg LR-M. Grounded theory in public health research. In: Hallberg LR-M, ed. Qualitative methods in public health research: theoretical foundations and practical examples. Lund: Studentlitteratur, 2002; 137-173.
  • Glaser B, Strauss A. The discovery of grounded theory: strategies for qualitative research. New York: Aldine de Gruyter, 1967.
  • Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3. PubMed 27501304 ↗

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04064853
Lead sponsor
Malmö University
Responsible party
Henrik Berlin (DDS, senior lecturer, Malmö University) — Principal investigator
First posted
Aug 22, 2019
Start date
Apr 5, 2019
Primary completion
Mar 16, 2020
Completion
Mar 1, 2022
Last update
Mar 15, 2023

Study contacts

Henrik Berlin, DDS
principal investigator · Malmö University, Faculty of Odontology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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