Thyroid DiseaseTeachBackThyrNCT07277647
Effects of a Head and Neck Stretching Exercise Program With Teach-Back-Based Education on Voice Quality, Anxiety, and Psychological Resilience After Thyroidectomy
A study testing Structured patient education + neck stretching exercises in people with Thyroid Disease, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Disease
- What is being tested?
- Structured patient education + neck stretching exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2023to 12 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 to 65,
- Possessing adequate oxygen capacity,
- Capable of communicating in Turkish,
- And volunteering to participate in the study were included.
Who cannot join
- Individuals who had previously undergone a partial thyroidectomy,
- Those with pre-existing cervical issues prior to thyroidectomy,
- And those with current or past voice disorders, or any condition that might impair decision-making capacity (such as psychological impairment, dementia, etc.), were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Research Hospital, Erzurum, Türkiye
Erzurum, 25000
About this study
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:
Read more
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.
- Conditions
- Thyroid Disease
- Being tested
- Structured patient education + neck stretching exercises
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured patient education + neck stretching exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | Structured patient education + neck stretching exercises Receives: Behavioral: Structured patient education + neck stretching exercises |
| Control Group | No intervention | routine care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Level,Connor-Davidson Resilience Scale (CD-RISC),Voice Handicap
State-Trait Anxiety Inventory (STAI) State anxiety will be assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-S). The STAI-S consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
Connor-Davidson Resilience Scale (CD-RISC) Psychological resilience will be assessed using the Connor-Davidson Resilience Scale (CD-RISC-25). The scale consists of 25 items rated on a 5-point Likert scale. Total scores range from 0 to 100, with higher scores indicating greater psychological resilience.
Voice Handicap Index-10 (VHI-10) Voice-related disability will be assessed using the Voice Handicap Index-10 (VHI-10). The VHI-10 consists of 10 items rated on a 5-point Likert scale. Total scores range from 0 to 40, with higher scores indicating greater perceived voice handicap.
Measured: Preoperative, postoperative 1st day, 1st week, 2nd week and 1st month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start12 May 2023
- Primary completion12 May 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study is a non-randomized, quasi-experimental study using a pretest-posttest control group design. Participants undergoing thyroidectomy were assigned sequentially to either a control group receiving routine nursing care or an intervention receiving group a teach-back-based perioperative education program in addition to routine care. Groups were formed consecutively rather than simultaneously to prevent information exchange between participants in the same ward. Outcome measures were assessed at baseline (preoperatively) and on postoperative day 1, week 1, week 2, and month 1. Blinding was not performed for the intervention provider; However, statistical analyzes were conducted by an independent statistician.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasemin ay karadaş, Ataturk University
- Investigators
- Prof. Dr. NEZİHA KARABULUT, Principal Investigator, Study director, Ataturk University Faculty of Nursing, Erzurum, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277647
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/359
- Acronym
- TeachBackThyr
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared in order to protect participant confidentiality and because the ethical approval for this study limits data use to the current research purposes only.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Head and Neck Stretching Exercise Program With Teach-Back-Based Education on Voice Quality, Anxiety, and Psychological Resilience After Thyroidectomy
- ClinicalTrials.gov ID
- NCT07277647
- Acronym / sponsor ID
- TeachBackThyr / B.30.2.ATA.0.01.00/359
- Conditions
- Thyroid Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a non-randomized, quasi-experimental study using a pretest-posttest control group design. Participants undergoing thyroidectomy were assigned sequentially to either a control group receiving routine nursing care or an intervention receiving group a teach-back-based perioperative education program in addition to routine care. Groups were formed consecutively rather than simultaneously to prevent information exchange between participants in the same ward. Outcome measures were assessed at baseline (preoperatively) and on postoperative day 1, week 1, week 2, and month 1. Blinding was not performed for the intervention provider; However, statistical analyzes were conducted by an independent statistician.
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Behavioral: Structured patient education + neck stretching exercisesStructured patient education + neck stretching exercises |
| Control Group | No intervention | –routine care only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 18 to 65,
- Possessing adequate oxygen capacity,
- Capable of communicating in Turkish,
- And volunteering to participate in the study were included.
Key exclusion criteria (3 listed)
- Individuals who had previously undergone a partial thyroidectomy,
- Those with pre-existing cervical issues prior to thyroidectomy,
- And those with current or past voice disorders, or any condition that might impair decision-making capacity (such as psychological impairment, dementia, etc.), were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured patient education + neck stretching exercisesThe 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. | Behavioural | Education Group |
Primary outcome
State Anxiety Level,Connor-Davidson Resilience Scale (CD-RISC),Voice Handicap
Time frame: Preoperative, postoperative 1st day, 1st week, 2nd week and 1st month.
State-Trait Anxiety Inventory (STAI) State anxiety will be assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-S). The STAI-S consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety. Connor-Davidson Resilience Scale (CD-RISC) Psychological resilience will be assessed using the Connor-Davidson Resilience Scale (CD-RISC-25). The scale consists of 25 items rated on a 5-point Likert scale. Total scores range from 0 to 100, with higher scores indicating greater psychological resilience. Voice Handicap Index-10 (VHI-10) Voice-related disability will be assessed using the Voice Handicap Index-10 (VHI-10). The VHI-10 consists of 10 items rated on a 5-point Likert scale. Total scores range from 0 to 40, with higher scores indicating greater perceived voice handicap.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared in order to protect participant confidentiality and because the ethical approval for this study limits data use to the current research purposes only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. NEZİHA KARABULUT, Principal Investigator study director
Ataturk University Faculty of Nursing, Erzurum, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured patient education + neck stretching exercises in people with Thyroid Disease, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Level,Connor-Davidson Resilience Scale (CD-RISC),Voice Handicap (time frame: Preoperative, postoperative 1st day, 1st week, 2nd week and 1st month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.