- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277647
The Effect of Head and Neck Stretching Exercises on Voice, Anxiety and Psychological Resilience After Thyroidectomy
The aim of this clinical randomized controlled trial is to evaluate the effects of head and neck stretching exercises performed after thyroidectomy on voice function, anxiety, and psychological resilience, and to examine the effectiveness of this intervention in adult patients undergoing thyroidectomy.
The primary questions to be answered are:
Do head and neck stretching exercises improve voice function (Voice Handicap Index) after thyroidectomy? Do head and neck stretching exercises reduce patients' anxiety levels and increase psychological resilience? As a comparison group, researchers will compare the effects of head and neck stretching exercises to a control group receiving only routine care to assess the effects of exercises on voice, anxiety, and psychological resilience.
Participants will be asked to participate in the following procedures:
Patients in the experimental group will undergo head and neck stretching exercises in the early post-thyroidectomy period.
Voice function, anxiety, and psychological resilience will be measured in both groups before surgery and at postoperative day 1, week 1, week 2, and month 1.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey (Türkiye), 25000
- Atatürk University Research Hospital, Erzurum, Türkiye
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 18 and 65, with adequate cognitive functions, who could communicate in Turkish, and who volunteered to participate in the study were included in our study.
Exclusion Criteria:
- Individuals who had previously undergone partial thyroidectomy, had cervical problems before thyroidectomy, had current or previous voice disorders, or had any illness that could affect decision-making ability (psychological disorder, dementia, etc.) were not included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education Group
Structured patient education + neck stretching exercises
|
The intervention is a nurse-led, structured patient education program based on the, combined with a supervised head-neck stretching exercise program.
Unlike routine postoperative care, this intervention includes: (1) preoperative individualized education using the Teach-Back method, (2) a printed educational booklet specifically developed for thyroidectomy patients, and (3) a standardized 30-day head-neck stretching exercise program initiated in the early postoperative period (starting on postoperative day 1).
The exercise program is performed daily at home with visual and written guidance.
In addition, patients receive regular follow-up and reinforcement during the postoperative period.
This comprehensive and multimodal structure distinguishes the intervention from standard care and other single-component educational approaches.
|
|
No Intervention: Control Group
routine care only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Level
Time Frame: Preoperative, postoperative 1st day, 1st week, 2nd week and 1st month.
|
State anxiety level will be measured using the State-Trait Anxiety Inventory (STAI).
|
Preoperative, postoperative 1st day, 1st week, 2nd week and 1st month.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: NEZİHA KARABULUT, Principal Investigator, Ataturk University Faculty of Nursing, Erzurum, Türkiye
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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