Diet Education and Postoperative Outcomes in Pediatric Adenotonsillectomy

NCT06988748 | Not Yet Recruiting

• 1 other identifier: 2025/05-15
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effect of tonsillectomy diet education on postoperative bleeding and pain in children undergoing adenotonsillectomy. Seventy-six pediatric patients will be randomly assigned to either an intervention group, which will receive specific diet education prior to surgery, or a control group receiving standard care. Bleeding and pain will be assessed at 4, 8, and 24 hours, and on the 7th day after surgery using a specialized follow-up form and the Wong-Baker Faces Pain Rating Scale. The study hypothesizes that diet education will reduce postoperative bleeding and pain, improving recovery and quality of life in children.

Conditions

Adenotonsillar Hypertrophy

Keywords

Adenotonsillectomy; Child; Diet Education; Tonsillectomy Diet; Postoperative Bleeding; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Follow-up and Evaluation Form for Children After Adenotonsillectomy

  The time and number of evaluations; 4th hour after surgery will be considered as 1st evaluation, 8th hour after surgery as 2nd evaluation, 24th hour after surgery as 3rd evaluation, 7th day after surgery as 4th evaluation. The first 3 evaluations will be during hospitalization. The next 7th day evaluation will be evaluated on the 7th day when the child and caregiver are discharged and come for follow-up.

  4th hour after surgery 1st assessment, 8th hour after surgery 2nd assessment, 24th hour after surgery 3rd assessment, 7th day after surgery 4th assessment. The first 3 assessments will be duri

Study Arms (2)

research group

EXPERIMENTAL

The children in the research group and their caregivers will be trained in line with the content of the "Training manual" using lecture and power point presentation methods. Power point presentation training will be given via computer. Before the training, the researcher will briefly introduce himself/herself with a sincere tone of voice to create a reassuring environment. The researcher will then explain the purpose, topic and duration of the study. The researcher will explain to the children and their caregivers that they can express their thoughts or ask questions about the topic during the training

Other: Assigned Interventions (diet training)

control group

NO INTERVENTION

Children in the control group will receive a normal education in line with the clinic functioning. No training on tonsillectomy diet will be given by the investigator.

Interventions

Assigned Interventions (diet training) OTHER

Pain and bleeding will be evaluated at 4 hours, 8 hours, 24 hours and 7 days after adenotonsillectomy by using "Wong-Baker Faces Pain Rating Scale" and "Follow-up and Evaluation Form for Children After Adenotonsillectomy in Children".

research group

Eligibility Criteria

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

You may qualify if:

• The child being sick,
• The child will have an adenotonsillectomy,
• The child has no milk allergy (to exclude children at risk of developing milk allergy during the data collection process),
• The child's caregiver stays with the child during the research process (to avoid communication barriers and disruptions in treatment and care instructions during the training and data collection process),
• The child and caregiver can speak and understand Turkish (to avoid communication barriers during the training and data collection process),
• The child's caregiver agrees to the research,
• Children without swallowing difficulties and aspiration risk (e.g. nasogastric catheter, tracheostomy)
• Children without diseases that cause maladaptive behavior (e.g. autism, cerebral palsy)

You may not qualify if:

• The child has a milk allergy,
• Children with diseases that cause swallowing difficulties, risk of aspiration and maladaptive behavior (e.g. autism, cerebral palsy)
• Failure of the child and caregiver to attend the follow-up examination on the 7th day after surgery

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Hilal AKDENİZ

Istanbul, Ataşehir, 34000, Turkey (Türkiye)

Location

Related Publications (11)

• Windfuhr JP, Chen YS, Remmert S. Hemorrhage following tonsillectomy and adenoidectomy in 15,218 patients. Otolaryngol Head Neck Surg. 2005 Feb;132(2):281-6. doi: 10.1016/j.otohns.2004.09.007.

  PMID: 15692542 BACKGROUND

• Bellis JR, Pirmohamed M, Nunn AJ, Loke YK, De S, Golder S, Kirkham JJ. Dexamethasone and haemorrhage risk in paediatric tonsillectomy: a systematic review and meta-analysis. Br J Anaesth. 2014 Jul;113(1):23-42. doi: 10.1093/bja/aeu152.

  PMID: 24942713 BACKGROUND

• Gulsen S, Cikrikci S. Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Eustachian Tube Function. J Craniofac Surg. 2020 Jun;31(4):919-923. doi: 10.1097/SCS.0000000000006039.

  PMID: 31764564 BACKGROUND

• Meybodian M, Dadgarnia M, Baradaranfar M, Vaziribozorg S, Mansourimanesh M, Mandegari M, Saeidi Eslami N. Effect of Cold Diet and Diet at Room Temperature on Post-Tonsillectomy Pain in Children. Iran J Otorhinolaryngol. 2019 Mar;31(103):81-86.

  PMID: 30989073 BACKGROUND

• Ashbach MN, Ostrower ST, Parikh SR. Tonsillectomy techniques and pain: a review of randomized controlled trials and call for standardization. ORL J Otorhinolaryngol Relat Spec. 2007;69(6):364-70. doi: 10.1159/000108369. Epub 2007 Nov 23.

  PMID: 18033974 BACKGROUND

• Boroumand P, Zamani MM, Saeedi M, Rouhbakhshfar O, Hosseini Motlagh SR, Aarabi Moghaddam F. Post tonsillectomy pain: can honey reduce the analgesic requirements? Anesth Pain Med. 2013 Summer;3(1):198-202. doi: 10.5812/aapm.9246. Epub 2013 Jul 1.

  PMID: 24223362 BACKGROUND

• Ostvoll E, Sunnergren O, Ericsson E, Hemlin C, Hultcrantz E, Odhagen E, Stalfors J. Mortality after tonsil surgery, a population study, covering eight years and 82,527 operations in Sweden. Eur Arch Otorhinolaryngol. 2015 Mar;272(3):737-43. doi: 10.1007/s00405-014-3312-z. Epub 2014 Oct 2.

  PMID: 25274044 BACKGROUND

• Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.

  PMID: 24407716 BACKGROUND

• Albeladi MA, Salamah MA, Alhussaini R. The Effect of Ice Cream Intake on Pain Relief for Patients After Tonsillectomy. Cureus. 2020 Jul 9;12(7):e9092. doi: 10.7759/cureus.9092.

  PMID: 32789040 BACKGROUND

• Soleymanifard F, Khademolhoseyni SM, Nouri JM. Nursing process in post tonsillectomy pain diagnosis: a systematic review. Glob J Health Sci. 2014 Aug 22;7(1):180-7. doi: 10.5539/gjhs.v7n1p180.

  PMID: 25560345 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

MeSH Terms

Conditions

Postoperative Hemorrhage; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hilal AKDENİZ

  Maltepe University School of Nursing İstanbul, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Behice EKİCİ, Doç. Dr.

CONTACT

05304192137; behiceekici@maltepe.edu.tr

Hilal Akdeniz

CONTACT

5350269472; 231501201@st.maltepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: research and control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Model Details: Parallel Assignment research and control group

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: June 20, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)