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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04064853
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : November 27, 2020
Information provided by (Responsible Party):
Henrik Berlin, Malmö University

Brief 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?

Condition or disease
Attitude Pain, Postoperative Pain, Procedural Child Adolescent Tooth Extraction

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Childrens' Experiences of Pain in Conjunction With Tooth Extraction - a Grounded Theory
Actual Study Start Date : April 5, 2019
Actual Primary Completion Date : March 16, 2020
Estimated Study Completion Date : December 4, 2020

Primary Outcome Measures :
  1. Children's experiences during and after tooth extraction, and it's consequences [ Time Frame: Fall 2019 ]
    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?".

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04064853

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Contact: Henrik Berlin, DDS 0046 40 665 84 88
Contact: Gunilla Klingberg, Dean 0046 40 665 84 85

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Faculty of Odontology, Malmö University Recruiting
Malmö, Scania, Sweden, SE-20506
Contact: Henrik Berlin, DDS    0046 40665 84 88   
Contact: Gunilla Klingberg, Professor    0046 40 665 84 85   
Sponsors and Collaborators
Malmö University
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Principal Investigator: Henrik Berlin, DDS Malmö University, Faculty of Odontology
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.

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Responsible Party: Henrik Berlin, DDS, senior lecturer, Malmö University Identifier: NCT04064853    
Other Study ID Numbers: GT dental pain Malmo U
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henrik Berlin, Malmö University:
grounded theory
postoperative pain
procedural pain
tooth extraction
Additional relevant MeSH terms:
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Pain, Postoperative
Pain, Procedural
Postoperative Complications
Pathologic Processes
Neurologic Manifestations