Children Recovering From Tonsil Surgery

NCT03292068 | Unknown

• 1 other identifier: TONIST
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillitis

Outcome Measures

Primary Outcomes (1)

• Sore throat item, in the instrument Postoperative Recovery in Children instrument (PRiC), change assessed

  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.

  On the surgery day, Daily during the postoperative days 1-7 and during the 10:th, 14:th and the 21:th day

Secondary Outcomes (8)

• Numerical Rating Scale, NRS (0-10) Nausea

  Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2

• Postoperative Recovery in Children, PRiC, Questionaire.

  Daily during the postoperative days 1-7 and during the 10:th, 14:th and the 21:th day

• EQ5D Economic effect between, assessment of change

  On the 14:th day before surgery, Daily during the 10:th, 14:th and the 21:th postoperative days

• Protocol and diary for telephone follow up, assessment of change

  On the first postoperative day and on the 3:rd, 5:th och 10:th day postoperatively.

• Diary for acupuncture and acupressure, assessment of change

  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.

Study Arms (3)

Acupuncture, acupressure

EXPERIMENTAL

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

Timbal diet

EXPERIMENTAL

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

Extended telephone counseling

OTHER

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

Interventions

Acupuncture, acupressure COMBINATION_PRODUCT

Intervention group will receive usual care in combination with Pyonex-needles and "Kulplåster". The control group will only receive usual care.

Also known as: Pyonex-needles (Seirin, 1.5 mm long), "Kulplaster" (1.5 mm ball)

Acupuncture, acupressure

Timbal diet DIETARY_SUPPLEMENT

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.

Also known as: Protein-enriched ice cream, made with egg yolks and cream

Timbal diet

Extended telephone counseling OTHER

Intervention group will receive usual care in combination with Extended telephone counseling. The control group will only receive usual care.

Extended telephone counseling

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Helena Rosén

Lund, 22100, Sweden

RECRUITING

Related Publications (15)

• Allvin R, Berg K, Idvall E, Nilsson U. Postoperative recovery: a concept analysis. J Adv Nurs. 2007 Mar;57(5):552-8. doi: 10.1111/j.1365-2648.2006.04156.x.

  PMID: 17284272 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Stalfors, J. (2015). Registerdata från Öron-, Näs- och Hals kvalitetsregister (2015) PDF Rapport ISSN 1400-0121 SVENSK ÖNH-TIDSKRIFT 22(3).

  BACKGROUND

• 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.)

  BACKGROUND

• Stanko D, Bergesio R, Davies K, Hegarty M, von Ungern-Sternberg BS. Postoperative pain, nausea and vomiting following adeno-tonsillectomy - a long-term follow-up. Paediatr Anaesth. 2013 Aug;23(8):690-6. doi: 10.1111/pan.12170. Epub 2013 May 13.

  PMID: 23668258 BACKGROUND

• Paquette J, Le May S, Lachance Fiola J, Villeneuve E, Lapointe A, Bourgault P. A randomized clinical trial of a nurse telephone follow-up on paediatric tonsillectomy pain management and complications. J Adv Nurs. 2013 Sep;69(9):2054-65. doi: 10.1111/jan.12072. Epub 2013 Jan 13.

  PMID: 23311981 BACKGROUND

• Sutters KA, Savedra MC, Miaskowski C. The pediatric PRO-SELF(c): pain control program: an effective educational program for parents caring for children at home following tonsillectomy. J Spec Pediatr Nurs. 2011 Oct;16(4):280-94. doi: 10.1111/j.1744-6155.2011.00299.x. Epub 2011 Aug 12.

  PMID: 21951354 BACKGROUND

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.

  PMID: 18824488 BACKGROUND

• Mohler R, Kopke S, Meyer G. Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). Trials. 2015 May 3;16:204. doi: 10.1186/s13063-015-0709-y.

  PMID: 25935741 BACKGROUND

• Segerdahl M, Warren-Stomberg M, Rawal N, Brattwall M, Jakobsson J. Children in day surgery: clinical practice and routines. The results from a nation-wide survey. Acta Anaesthesiol Scand. 2008 Jul;52(6):821-8. doi: 10.1111/j.1399-6576.2008.01669.x. Epub 2008 May 21.

  PMID: 18498436 BACKGROUND

• Bramhagen AC, Eriksson M, Ericsson E, Nilsson U, Harden S, Idvall E. Self-reported post-operative recovery in children: development of an instrument. J Eval Clin Pract. 2016 Apr;22(2):180-8. doi: 10.1111/jep.12451. Epub 2015 Oct 13.

  PMID: 26460499 BACKGROUND

• Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.

  PMID: 9366889 BACKGROUND

• Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.

  PMID: 14769454 BACKGROUND

• Gudnadottir G, Persson RG, Drevenhorn E, Olofsson E, Rosen H. The effect of telephone counseling and internet-based support on pain and recovery after tonsil surgery in children - a systematic review. Int J Nurs Stud Adv. 2021 Apr 22;3:100027. doi: 10.1016/j.ijnsa.2021.100027. eCollection 2021 Nov.

  PMID: 38746736 DERIVED

MeSH Terms

Conditions

Tonsillitis

Interventions

Acupuncture Therapy; Acupressure; Egg Yolk

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Therapy, Soft Tissue; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation; Eggs; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Helena i Rosén, PhD

  Health scienses, Faculty of medicine, Lund University

  PRINCIPAL INVESTIGATOR

• Lena-karin Erlandsson, PhD

  Health scienses, Faculty of medicine, Lund University

  STUDY DIRECTOR

Central Study Contacts

Helena I Rosén, PhD

CONTACT

+46462221926; helena.rosen@med.lu.se

Eva BM Drevenhorn, PhD

CONTACT

+46462221928; eva.drevenhorn@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: September 25, 2017
• Study Start: January 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)