The Effect of Mobile-Based Education on Postoperative Recovery and Quality of Life in Thyroidectomy Patients
1 other identifier
interventional
92
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2024
CompletedStudy Start
First participant enrolled
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2025
CompletedApril 26, 2024
April 1, 2024
1 year
April 21, 2024
April 24, 2024
Conditions
Keywords
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
EXPERIMENTALAfter 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.
Control Group
NO INTERVENTIONControl 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.
Eligibility Criteria
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: 23688791BACKGROUNDSnyder 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: 20421007BACKGROUNDAdam 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: 28059969BACKGROUNDAtasayar 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: 28882054BACKGROUNDKrekeler 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: 29522149BACKGROUNDWatt 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: 19288224BACKGROUNDTakamura 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
Condition Hierarchy (Ancestors)
Central Study Contacts
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