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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 : August 22, 2019
Information provided by (Responsible Party):
Henrik Berlin, Malmö University

Tracking Information
First Submitted Date August 20, 2019
First Posted Date August 22, 2019
Last Update Posted Date August 22, 2019
Actual Study Start Date April 5, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2019)
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?".
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Childrens' Experiences of Pain in Conjunction With Tooth Extraction - a Grounded Theory Study
Official Title Childrens' Experiences of Pain in Conjunction With Tooth Extraction - a Grounded Theory
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?
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
  • Attitude
  • Pain, Postoperative
  • Pain, Procedural
  • Child
  • Adolescent
  • Tooth Extraction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 20, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 27, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages 10 Years to 15 Years   (Child)
Accepts Healthy Volunteers Yes
Contact: Henrik Berlin, DDS 0046 40 665 84 88
Contact: Gunilla Klingberg, Dean 0046 40 665 84 85
Listed Location Countries Sweden
Removed Location Countries  
Administrative Information
NCT Number NCT04064853
Other Study ID Numbers GT dental pain Malmo U
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be shared.
Responsible Party Henrik Berlin, Malmö University
Study Sponsor Malmö University
Collaborators Not Provided
Principal Investigator: Henrik Berlin, DDS Malmö University, Faculty of Odontology
PRS Account Malmö University
Verification Date August 2019