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Trial record 7 of 19 for:    Recruiting, Not yet recruiting, Available Studies | "Tonsillitis"

Children Recovering From Tonsil Surgery (TONIST)

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ClinicalTrials.gov Identifier: NCT03292068
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Helena Rosén, PhD, Lund University

Brief Summary:

Children recovering from tonsil surgery following day surgery Tonsil surgery - self-care and treatment - the TONIST-study The main objective of this study is to evaluate the effect and experience of acupuncture, acupressure, specially designed diet and telephone counselling on children's surgery-related symptoms, quality of life and costs during recovery after tonsillectomy (TE) or tonsillotomy (TT).

Early discharge from hospitals means that patients have to deal with much of the post-operative care during recovery process on their own or with the help of relatives. The recovery period may be a progressive process of physical weakness (1,2).

In Sweden, 14 000 tonsil surgeries per year are performed, about 50% children under 15 years because of obstruction, of TE, tonsillectomy, and TT, tonsillomy. Children's tonsil surgery following day surgery are in focus for this study. Both qualitative and quantitative methods will be used.


Condition or disease Intervention/treatment Phase
Tonsillitis Combination Product: Acupuncture, acupressure Dietary Supplement: Timbal diet Other: Extended telephone counseling Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Triangulation design will be used including both qualitative and quantitative methods. All the intervention groups will receive usual care in combination with a special intervention. The control group will only receive usual care. In the study the three interventions will be performed at one hospital each.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Children Recovering From Tonsil Surgery Following Day Surgery
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Experimental: Acupuncture, acupressure

Intervention with Pyonex-needles & Usual care; applied to the acupoints LI4 , LI11, PC6 and ST36 bilaterally before surgery. Pyonex needles are embedded in a 2 mm round plastic piece sitting on a round, skin friendly patch of about 8 mm in diameter. The patch can remain for seven days. The needle can be stimulated by gently touches the plastic bubble by the patch.

Intervention Acupressure & Usual care; a 'kulplåster (1.5 mm a ball on a small piece of adhesive tape) both ears before postoperative drug administration. Kulplåster can remain for ten days or until they fall off. Children and their parents will be asked to fill in a diary of when the needle is stimulated, for what reason and when the symptoms are alleviated. In the diary is also filled in on the kulplåster remains.

Combination Product: Acupuncture, acupressure
Intervention group will receive usual care in combination with Pyonex-needles and "Kulplåster". The control group will only receive usual care.
Other Names:
  • Pyonex-needles (Seirin, 1.5 mm long)
  • "Kulplaster" (1.5 mm ball)

Experimental: Timbal diet
Timbal diet including ice cream & Usual care.The specially designed diet, originally made for patients suffering of dysphagia, named "timbalkost" will be used. The specially designed food/diet, "timbalkost" will be given as lunch and dinner. The consistency of timbalkost is smooth. It does not require more thorough processing of the mouth. As a snack, a protein-enriched ice cream, made with egg yolks and cream, will be made available. The food will be given to the child for 3-7 days depending on how quickly the child can return to normal food. A powder that jellify liquids to facilitate swallowing will also be used if and when needed. The children or their parents will be asked to fill in a food diary during one week after surgery.
Dietary Supplement: Timbal diet
Intervention group will receive usual care in combination Timbal diet including Protein-enriched ice cream, made with egg yolks and Cream. The control group will only receive usual care.
Other Name: Protein-enriched ice cream, made with egg yolks and cream

Extended telephone counseling
Extended telephone counseling & Usual care : A nurse will contact the child, or the child´s parents, by telephone on day 1, 3, 5 and 10 for extended telephone counseling postoperatively (POD), to provide support and information. The child's well-being will be assessed, response given to queries and concerns, advice and explanations related to the problems expressed or identified, proper interventions will be promoted and reassurance provided. The nurse will fill in a protocol on what topics the counseling was about at each call and the child and/or parent a diary.
Other: Extended telephone counseling
Intervention group will receive usual care in combination with Extended telephone counseling. The control group will only receive usual care.




Primary Outcome Measures :
  1. Sore throat item, in the instrument Postoperative Recovery in Children instrument (PRiC), change assessed [ Time Frame: On the surgery day, Daily during the postoperative days 1-7 and during the 10:th, 14:th and the 21:th day ]

    Sore throat measured with the PRiC, instrument. Sore throat with the opportunity to grade the answer Not at all, A little, alternatively Much or Very much.

    Estimates for the number of children who need to be included in the study is based on the distribution of responses to the question "sore throat" that is, a sore throat the last 24 hours from the questionnaire PRiC. The control group is assumed to respond to the same distribution as the children in Bramhagen et al (2016) and the children in the intervention group is assumed to have a positive shift in the distribution of answers.



Secondary Outcome Measures :
  1. Numerical Rating Scale, NRS (0-10) Nausea [ Time Frame: Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2 ]
    Nausea on a scale NRS (0-10)

  2. Postoperative Recovery in Children, PRiC, Questionaire. [ Time Frame: Daily during the postoperative days 1-7 and during the 10:th, 14:th and the 21:th day ]
    Measuring change in postoperative recovery in children emotional state.

  3. EQ5D Economic effect between, assessment of change [ Time Frame: On the 14:th day before surgery, Daily during the 10:th, 14:th and the 21:th postoperative days ]
    Quality of life and health

  4. Protocol and diary for telephone follow up, assessment of change [ Time Frame: On the first postoperative day and on the 3:rd, 5:th och 10:th day postoperatively. ]
    postoperative problems that arise, assessment of these and reference to the healthcare institution if necessary

  5. Diary for acupuncture and acupressure, assessment of change [ Time Frame: On the surgery day and daily on the postoperative days 1 to at 10. Measurement to the high tenth day postoperatively depending on whether the child is using the APU and / or LFS for so long. ]
    Documentation of when akupunkture or acupressure is given , for what reason and when removed

  6. Diary for specially designed diet including ice Cream, assessment of change [ Time Frame: As long as meals are consumed, daily, up to 10 days following surgery day. ]
    Diary documentation, number of meals.

  7. Numerical Rating Scale, NRS (0-10) anxiety [ Time Frame: Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2 ]
    Anxiety on a scale NRS (0-10)

  8. Numerical Rating Scale, NRS (0-10) [ Time Frame: Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2 ]
    Pain on a scale NRS (0-10)



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Ages Eligible for Study:   2 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Children, 2-19 years of age who undergo Tonsillectomy or Tonsillotomi be asked to participate.

Exclusion Criteria:

For children who have aversion, intolerance or allergy to ice cream or any of the ingredients in it the exclusion of the ice cream as a snack will be done.


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 ClinicalTrials.gov identifier (NCT number): NCT03292068


Contacts
Contact: Helena I Rosén, PhD +46462221926 helena.rosen@med.lu.se
Contact: Eva BM Drevenhorn, PhD +46462221928 eva.drevenhorn@med.lu.se

Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Helena i Rosén, PhD Health scienses, Faculty of medicine, Lund University
Study Director: Lena-karin Erlandsson, PhD Health scienses, Faculty of medicine, Lund University

Publications:
Jakobsson, J. (2017). The process of recovery after colorectal cancer surgery : patients' experiences and factors of influence. Malmö högskola. Fakulteten för hälsa och samhälle, Malmö University Doctoral Dissertation: 93.
Young, J., et al. (2000). Day surgery patients' convalescence at home: Does enhanced discharge education make a difference? Nursing & Health Sciences 2(1): 29-39.
Stalfors, J. (2015). Registerdata från Öron-, Näs- och Hals kvalitetsregister (2015) PDF Rapport ISSN 1400-0121 SVENSK ÖNH-TIDSKRIFT 22(3).
Ericsson, Elisabeth. (2007). Health and well-being of children and young adults in relation to surgery of the tonsils. (Medical dissertation), Linköping University Linköping, Sweden. (No. 992.)

Responsible Party: Helena Rosén, PhD, Principal investigator, Lund University
ClinicalTrials.gov Identifier: NCT03292068     History of Changes
Other Study ID Numbers: TONIST
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: I have not decided to make individual participant data (IPD) available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases