NCT06383481

Brief Summary

Thyroid diseases constitute one of the most common health problems around the world and in our country. In its treatment; Drug therapy, radioactive iodine therapy and surgical treatment can be applied alone or together. Advances in the diagnosis of thyroid diseases have led to an increase in the number of thyroidectomies. When there are no complications after thyroidectomy, patients are discharged from the hospital on the day of surgery or are hospitalized for only a few days. In this context, since technical care is given priority, discharge training remains incomplete. Patients who have had thyroidectomy are discharged within 1-2 days after surgery if no problems occur. For this reason, patient education provided by health professionals and especially nurses may be insufficient. Post-discharge patient education in surgical services can sometimes be ignored, and it is noteworthy that this situation is not given importance due to the busy nature of surgical services. Although short hospital stays after surgery are beneficial in many ways, it increases the need for patient education. In this study, a mobile application that covers the entire perioperative process and includes education will be developed for patients undergoing thyroidectomy. This developed mobile application aims to manage post-operative problems such as neck pain and discomfort and voice changes experienced by patients, and to improve post-operative recovery, voice quality and, accordingly, quality of life. In this context, it is believed that even in cases where patients cannot access health care professionals, their educational needs will be met, problem management will be provided with applications for the problems they experience, and accordingly, their post-operative recovery, voice and quality of life will increase, starting from the hospital before the surgery until the end of the recovery period, including the home care process after discharge.When the literature on the subject is examined, studies involving education in patients with thyroidectomy are limited. However, no studies have been found on mobile health applications that include training to reduce neck pain and discomfort experienced by thyroidectomy patients, ensure postoperative recovery, and improve voice quality and quality of life.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2025

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 21, 2024

Last Update Submit

April 24, 2024

Conditions

Keywords

ThyroidectomyPatientMobile-Based EducationPostoperative RecoveryQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Postoperative Recovery Index (ASII)

    Postoperative Healing Index Butler et al. It was developed by in 2012. ASII has five subscales. These are psychological symptoms, physical activities, general symptoms, intestinal symptoms and desire-desire symptoms. A higher score from the index indicates more difficulty in postoperative recovery, while lower scores indicate that postoperative recovery is easier.

    1st day after surgery, 1st week after surgery, 4th week after surgery, 12th week after surgery

  • SF-36 Quality of Life Scale

    The validity and reliability study of the SF-36 Quality of Life Scale, developed by Rand Corporation in 1992 to evaluate the quality of life, in Turkish society was conducted by Pınar. SF-36; It examines the sub-dimensions of physical function, social function, physical role difficulty, emotional role difficulty, mental health, vitality/fatigue, pain, and general health perception in 36 items. Scores of the subscales range from 0 to 100, and a low score indicates poor health status. The scale is Likert type, except for some items, and there are items that include thoughts about the change in health considering the last 4 weeks. The fourth and fifth questions in the scale are evaluated with yes/no, and the other questions are evaluated with Likert type (3-point, 5-point, 6-point) rating. The score is calculated by reversing items 1, 6, 7, 8, 9a, 9d, 9e, 9h, 11b, 11d of the scale.

    1 day before surgery,1st day after surgery, 4th week after surgery, 12th week after surgery

Secondary Outcomes (4)

  • Visual Comparison Pain Scale(GKAÖ)

    1 day before surgery,1st day after surgery, 1st week after surgery, 4th week after surgery, 12th week after surgery

  • Turkish- Computer System Usability Questionnaire Short Version (TCSUQ- SV)

    1 day before surgery, 12th week after surgery

  • Neck Pain and Discomfort Scale (BARÖ)

    1 day before surgery, 1st week after surgery, 4th week after surgery, 12th week after surgery

  • Voice Handicap Index (Voice Handicap Index 10)(VHI10)

    1 day before surgery,1st day after surgery, 1st week after surgery, 4th week after surgery, 12th week after surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

After the mobile application is introduced to the patients, "T-CSUQ-SV" will be applied first. Following the introduction and information of the mobile application, the "Introductory Information Form, GKAÖ, BARÖ, VHI-10, SF-36 Quality of Life Scale" will be filled out face to face with the patients 1 day before the surgery. The mobile application will be available to the patient. On the first day after the surgery, patients will fill out the GKAÖ, VHI-10, Postoperative Recovery Index, and SF-36 Quality of Life Scale. During each meeting with patients, reminders will be given for the use of the mobile application, and it will be recommended that they read the information in the education section of the mobile application. In the 1st week after the surgery, patients will fill out GKAÖ, BARÖ, VHI-10, and Postoperative Recovery Index. At the 4th and 12th weeks after the surgery, patients will fill out the GKAÖ, BARÖ, VHI-10, Postoperative Recovery Index, SF-36 Quality of Life Scale.

Other: Mobile based education

Control Group

NO INTERVENTION

Control Group Patients in the control group will be provided with standard patient care and information. No application will be made. In summary, week 1 data collection forms will be filled out with the patients at the end of the first week. At the end of the 1st month, 1st month data collection forms will be filled out. At the end of the 3rd month, the study will be terminated by filling out the 3rd month data collection forms.

Interventions

Control Group Patients in the control group will be provided with standard patient care and information. No application will be made. Experimental group The mobile application will be downloaded to the phones of patients who can use the mobile application. The mobile application will be available to the patient. Patients will be informed about daily monitoring of the mobile application, following the training steps, and that they can reach the researcher with consultancy services whenever they need. The mobile application will be made available to patients within a 12-week period and patient follow-up will be provided.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years or older
  • Knowing how to read and write
  • Having a planned thyroidectomy
  • Having a thyroidectomy for the first time
  • Not having a mental/visual/hearing or speech disability
  • Not having any psychiatric disease
  • Owning and using a smartphone
  • Accessing the internet at home or on the phone
  • Volunteering to participate in the study

You may not qualify if:

  • Not agreeing to participate in the study
  • Having a mental/visual/hearing and speech disability
  • Having a psychiatric illness
  • Having had thyroid surgery before
  • Having had complications after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Vrabec S, Oltmann SC, Clark N, Chen H, Sippel RS. A short-stay unit for thyroidectomy patients increases discharge efficiency. J Surg Res. 2013 Sep;184(1):204-8. doi: 10.1016/j.jss.2013.04.036. Epub 2013 May 9.

    PMID: 23688791BACKGROUND
  • Snyder SK, Hamid KS, Roberson CR, Rai SS, Bossen AC, Luh JH, Scherer EP, Song J. Outpatient thyroidectomy is safe and reasonable: experience with more than 1,000 planned outpatient procedures. J Am Coll Surg. 2010 May;210(5):575-82, 582-4. doi: 10.1016/j.jamcollsurg.2009.12.037.

    PMID: 20421007BACKGROUND
  • Adam MA, Thomas S, Youngwirth L, Hyslop T, Reed SD, Scheri RP, Roman SA, Sosa JA. Is There a Minimum Number of Thyroidectomies a Surgeon Should Perform to Optimize Patient Outcomes? Ann Surg. 2017 Feb;265(2):402-407. doi: 10.1097/SLA.0000000000001688.

    PMID: 28059969BACKGROUND
  • Atasayar S, Guler Demir S. Determination of the Problems Experienced by Patients Post-Thyroidectomy. Clin Nurs Res. 2019 Jun;28(5):615-635. doi: 10.1177/1054773817729074. Epub 2017 Sep 7.

    PMID: 28882054BACKGROUND
  • Krekeler BN, Wendt E, Macdonald C, Orne J, Francis DO, Sippel R, Connor NP. Patient-Reported Dysphagia After Thyroidectomy: A Qualitative Study. JAMA Otolaryngol Head Neck Surg. 2018 Apr 1;144(4):342-348. doi: 10.1001/jamaoto.2017.3378.

    PMID: 29522149BACKGROUND
  • Watt T, Bjorner JB, Groenvold M, Rasmussen AK, Bonnema SJ, Hegedus L, Feldt-Rasmussen U. Establishing construct validity for the thyroid-specific patient reported outcome measure (ThyPRO): an initial examination. Qual Life Res. 2009 May;18(4):483-96. doi: 10.1007/s11136-009-9460-8. Epub 2009 Mar 14.

    PMID: 19288224BACKGROUND
  • Takamura Y, Miyauchi A, Tomoda C, Uruno T, Ito Y, Miya A, Kobayashi K, Matsuzuka F, Amino N, Kuma K. Stretching exercises to reduce symptoms of postoperative neck discomfort after thyroid surgery: prospective randomized study. World J Surg. 2005 Jun;29(6):775-9. doi: 10.1007/s00268-005-7722-3.

    PMID: 16078129BACKGROUND

Related Links

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Central Study Contacts

Beyzanur KIZILOĞLU AĞGÜL, phd student

CONTACT

Neziha KARABULUT, Prof.Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd student

Study Record Dates

First Submitted

April 21, 2024

First Posted

April 25, 2024

Study Start

April 22, 2024

Primary Completion

April 22, 2025

Study Completion

August 22, 2025

Last Updated

April 26, 2024

Record last verified: 2024-04