ThyroidectomyNCT07849946
Nurse-Led First-Night Preparation After Thyroidectomy
A study testing Nurse-Led First-Night Preparation Intervention in people with Thyroidectomy, run by Volkan Gokmen at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effect of a nurse-led "first-night preparation" intervention on quality of recovery, sleep quality, and symptom management in patients undergoing elective total thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- Nurse-Led First-Night Preparation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years of age or older) scheduled for elective total thyroidectomy at Agri Training and Research Hospital
- Hemodynamically stable
- Willing and able to provide written informed consent
- Able to understand and complete Turkish-language study questionnaires
Who cannot join
- Emergency (non-elective) thyroidectomy
- Revision or completion thyroidectomy
- Cognitive or communication impairment preventing informed consent or completion of study assessments
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Nurse-Led "First-Night Preparation" Intervention on Quality of Recovery in Postoperative Thyroidectomy Patients: A Randomized Controlled Trial
This study evaluates the effect of a nurse-led "first-night preparation" intervention on quality of recovery, sleep quality, and symptom management in patients undergoing elective total thyroidectomy. A total of 44 participants were randomly assigned to receive either the intervention, which includes brief preoperative information, postoperative first-night orientation, sleep-supportive environmental adjustments, and an optional brief guided relaxation technique, or standard postoperative care alone. The primary outcome is quality of recovery on the first postoperative day, measured with the Turkish-validated Quality of Recovery-15 (QoR-15T) scale. Secondary outcomes include sleep quality (RCSQ), pain (VAS/NRS), sore throat, dysphagia, analgesic consumption, patient satisfaction, and length of hospital stay. Data were collected within the first 24-48 hours after surgery.
Read the detailed description
The early postoperative period, particularly the first 24 hours, is a critical time for patients undergoing thyroidectomy, both physiologically and psychologically. Commonly reported symptoms in this period include pain, sore throat, dysphagia, voice changes, and neck discomfort, all of which can negatively affect patient comfort, daily function, and overall quality of recovery. Postoperative sleep disturbances are also common among surgical patients and may further impair pain perception, increase inflammatory response, and delay recovery. Although preoperative and postoperative patient education is common in clinical practice, it is often limited to general information and rarely addresses patients' specific experience of the first postoperative night, which may increase perceived uncertainty and symptom burden.This study uses a single-center, two-arm, parallel-group randomized controlled design to evaluate the effect of a nurse-led "first-night preparation" intervention on quality of recovery, sleep quality, and symptom management among adult patients undergoing elective total thyroidectomy at Agri Training and Research Hospital. Participants were randomly allocated to an intervention group or a control group using an independent-statistician-generated randomization sequence with variable permuted blocks (size 4/6), stratified by benign/malignant surgical indication; allocation concealment was maintained using sequentially numbered, opaque, sealed, tamper-evident (SNOSE) envelopes prepared and opened by study personnel independent of recruitment and outcome assessment. The intervention group receives a brief preoperative information session, postoperative first-night orientation upon arrival to the ward, sleep-supportive environmental adjustments (e.g., reducing light and noise), and an optional brief guided relaxation technique to facilitate sleep onset. The control group receives standard postoperative care only; no medication or routine care protocol is altered for either group.Data were collected during the preoperative period and within the first 24-48 postoperative hours. The primary outcome is quality of recovery on postoperative day 1, assessed with the Turkish-validated Quality of Recovery-15 (QoR-15T) scale (Kara et al., 2022). Secondary outcomes include sleep quality (Richards-Campbell Sleep Questionnaire, RCSQ), pain intensity (VAS/NRS), sore throat, dysphagia, postoperative nausea and vomiting, analgesic consumption, first-night control perception, patient satisfaction, and length of hospital stay. The study was approved by the Agri Ibrahim Cecen University Scientific Research Ethics Committee (decision no. 239, dated 30.04.2026) and is conducted in accordance with the Declaration of Helsinki, with written informed consent obtained from all participants. This trial was designed and powered as a randomized controlled trial with a planned sample size of 44 participants, and 44 participants were successfully randomized (84.6% of those screened).
- Conditions
- Thyroidectomy
- Being tested
- Nurse-Led First-Night Preparation Intervention
- Keywords
- Postoperative Care, Sleep Quality, Nursing Intervention, Quality of Recovery
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led First-Night Preparation InterventionBehavioural
A nurse-led intervention consisting of a brief preoperative information session, postoperative first-night orientation, sleep-supportive environmental adjustments, and an optional brief guided relaxation technique, delivered in addition to standard postoperative care.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led First-Night Preparation | Experimental | Participants receive a brief preoperative information session about the first postoperative night, postoperative first-night orientation upon arrival to the ward, sleep-supportive environmental adjustments (e.g., reducing light and noise), and an optional brief guided relaxation technique to facilitate sleep onset, in addition to standard postoperative care. Receives: Behavioral: Nurse-Led First-Night Preparation Intervention |
| Standard Care | No intervention | Participants receive standard postoperative care only, per routine clinical practice. No additional intervention, medication, or care protocol is altered for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QoR-15T Score)
Quality of recovery on postoperative day 1, assessed with the Turkish-validated Quality of Recovery-15 (QoR-15T; Kara et al., 2022) scale, which evaluates 15 items across five domains (pain, physical comfort, physical independence, psychological support, and emotional state) on a 0-10 scale. Total scores range from 0 to 150, with higher scores indicating better quality of recovery.
Measured: Postoperative Day 1 (within 24 hours after surgery)
Secondary outcomes (9)
Sleep Quality (Richards-Campbell Sleep Questionnaire Score)
Postoperative first-night sleep quality assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a 5-item visual analog scale measuring perceived sleep depth, sleep latency, number of awakenings, time spent awake, and overall sleep quality. Each item is scored 0-100, with higher scores indicating better sleep quality.
Measured: Assessed once, on the morning of postoperative day 1, reflecting the first postoperative night
Postoperative Pain Level (Numeric Rating Scale)
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS)/Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Assessed once, on postoperative day 1 (within the first 24 postoperative hours)
Postoperative Sore Throat Severity
Sore throat severity assessed using the Numeric Rating Scale (NRS), ranging from 0 (no sore throat) to 10 (worst imaginable sore throat).
Measured: Assessed once, on postoperative day 1 (within the first 24 postoperative hours)
Postoperative Dysphagia Severity
Difficulty swallowing (dysphagia) assessed using the Numeric Rating Scale (NRS), ranging from 0 (no difficulty swallowing) to 10 (worst imaginable difficulty swallowing).
Measured: Assessed once, on postoperative day 1 (within the first 24 postoperative hours)
Postoperative Analgesic Consumption
Total amount and type of analgesic (pain-relief) medication administered to the patient during the postoperative period, recorded from patient medication administration records.
Measured: Cumulative total over the first 24 postoperative hours
Patient Satisfaction with Postoperative Care
Patient-reported satisfaction with postoperative nursing care and the first-night preparation intervention, assessed using a 0-10 numeric rating scale (0 = not at all satisfied, 10 = extremely satisfied).
Measured: Postoperative Day 1
Length of Hospital Stay
Total duration of hospitalization, measured in hours from the time of surgery to the time of hospital discharge.
Measured: From surgery until hospital discharge, up to 48 hours
Postoperative Nausea and Vomiting (PONV)
Incidence and severity of postoperative nausea and vomiting (PONV), assessed using a numeric rating scale from 0 (none) to 10 (worst imaginable).
Measured: Assessed once, on postoperative day 1 (within the first 24 postoperative hours)
First-Night Control Perception
Patient's perceived sense of control and preparedness for the first postoperative night, assessed using a study-specific 4-item First-Night Control Perception scale developed for this trial (items scored 1-5 each; total score range 4-20, higher indicating greater perceived control).
Measured: Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start15 May 2026
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volkan Gokmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Volkan Gokmen, Agri Ibrahim Cecen University
- Investigators
- Burcu Demir Gokmen, Principal investigator, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849946
- Sponsor's protocol ID
- AICU-TIROID-IGH-2026
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing plan is currently available for this study.
Publications
Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
PubMed 36161615
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nurse-Led "First-Night Preparation" Intervention on Quality of Recovery in Postoperative Thyroidectomy Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07849946
- Acronym / sponsor ID
- AICU-TIROID-IGH-2026
- Conditions
- Thyroidectomy
- Keywords
- Postoperative Care, Sleep Quality, Nursing Intervention, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Volkan GokmenUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 30 Sep 2026 (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.
This study evaluates the effect of a nurse-led "first-night preparation" intervention on quality of recovery, sleep quality, and symptom management in patients undergoing elective total thyroidectomy. A total of 44 participants were randomly assigned to receive either the intervention, which includes brief preoperative information, postoperative first-night orientation, sleep-supportive environmental adjustments, and an optional brief guided relaxation technique, or standard postoperative care alone. The primary outcome is quality of recovery on the first postoperative day, measured with the Turkish-validated Quality of Recovery-15 (QoR-15T) scale. Secondary outcomes include sleep quality (RCSQ), pain (VAS/NRS), sore throat, dysphagia, analgesic consumption, patient satisfaction, and length of hospital stay. Data were collected within the first 24-48 hours after surgery.
Detailed description
The early postoperative period, particularly the first 24 hours, is a critical time for patients undergoing thyroidectomy, both physiologically and psychologically. Commonly reported symptoms in this period include pain, sore throat, dysphagia, voice changes, and neck discomfort, all of which can negatively affect patient comfort, daily function, and overall quality of recovery. Postoperative sleep disturbances are also common among surgical patients and may further impair pain perception, increase inflammatory response, and delay recovery. Although preoperative and postoperative patient education is common in clinical practice, it is often limited to general information and rarely addresses patients' specific experience of the first postoperative night, which may increase perceived uncertainty and symptom burden.This study uses a single-center, two-arm, parallel-group randomized controlled design to evaluate the effect of a nurse-led "first-night preparation" intervention on quality of recovery, sleep quality, and symptom management among adult patients undergoing elective total thyroidectomy at Agri Training and Research Hospital. Participants were randomly allocated to an intervention group or a control group using an independent-statistician-generated randomization sequence with variable permuted blocks (size 4/6), stratified by benign/malignant surgical indication; allocation concealment was maintained using sequentially numbered, opaque, sealed, tamper-evident (SNOSE) envelopes prepared and opened by study personnel independent of recruitment and outcome assessment. The intervention group receives a brief preoperative information session, postoperative first-night orientation upon arrival to the ward, sleep-supportive environmental adjustments (e.g., reducing light and noise), and an optional brief guided relaxation technique to facilitate sleep onset. The control group receives standard postoperative care only; no medication or routine care protocol is altered for either group.Data were collected during the preoperative period and within the first 24-48 postoperative hours. The primary outcome is quality of recovery on postoperative day 1, assessed with the Turkish-validated Quality of Recovery-15 (QoR-15T) scale (Kara et al., 2022). Secondary outcomes include sleep quality (Richards-Campbell Sleep Questionnaire, RCSQ), pain intensity (VAS/NRS), sore throat, dysphagia, postoperative nausea and vomiting, analgesic consumption, first-night control perception, patient satisfaction, and length of hospital stay. The study was approved by the Agri Ibrahim Cecen University Scientific Research Ethics Committee (decision no. 239, dated 30.04.2026) and is conducted in accordance with the Declaration of Helsinki, with written informed consent obtained from all participants. This trial was designed and powered as a randomized controlled trial with a planned sample size of 44 participants, and 44 participants were successfully randomized (84.6% of those screened).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led First-Night Preparation | Experimental | Behavioral: Nurse-Led First-Night Preparation InterventionParticipants receive a brief preoperative information session about the first postoperative night, postoperative first-night orientation upon arrival to the ward, sleep-supportive environmental adjustments (e.g., reducing light and noise), and an optional brief guided relaxation technique to facilitate sleep onset, in addition to standard postoperative care. |
| Standard Care | No intervention | –Participants receive standard postoperative care only, per routine clinical practice. No additional intervention, medication, or care protocol is altered for this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18 years of age or older) scheduled for elective total thyroidectomy at Agri Training and Research Hospital
- Hemodynamically stable
- Willing and able to provide written informed consent
- Able to understand and complete Turkish-language study questionnaires
Key exclusion criteria (4 listed)
- Emergency (non-elective) thyroidectomy
- Revision or completion thyroidectomy
- Cognitive or communication impairment preventing informed consent or completion of study assessments
- Refusal to participate
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 |
|---|---|---|
| Nurse-Led First-Night Preparation InterventionA nurse-led intervention consisting of a brief preoperative information session, postoperative first-night orientation, sleep-supportive environmental adjustments, and an optional brief guided relaxation technique, delivered in addition to standard postoperative care. | Behavioural | Nurse-Led First-Night Preparation |
Primary outcome
Quality of Recovery (QoR-15T Score)
Time frame: Postoperative Day 1 (within 24 hours after surgery)
Quality of recovery on postoperative day 1, assessed with the Turkish-validated Quality of Recovery-15 (QoR-15T; Kara et al., 2022) scale, which evaluates 15 items across five domains (pain, physical comfort, physical independence, psychological support, and emotional state) on a 0-10 scale. Total scores range from 0 to 150, with higher scores indicating better quality of recovery.
9 secondary outcomes
Sleep Quality (Richards-Campbell Sleep Questionnaire Score)
Time frame: Assessed once, on the morning of postoperative day 1, reflecting the first postoperative night
Postoperative Pain Level (Numeric Rating Scale)
Time frame: Assessed once, on postoperative day 1 (within the first 24 postoperative hours)
Postoperative Sore Throat Severity
Time frame: Assessed once, on postoperative day 1 (within the first 24 postoperative hours)
Postoperative Dysphagia Severity
Time frame: Assessed once, on postoperative day 1 (within the first 24 postoperative hours)
Postoperative Analgesic Consumption
Time frame: Cumulative total over the first 24 postoperative hours
Patient Satisfaction with Postoperative Care
Time frame: Postoperative Day 1
Length of Hospital Stay
Time frame: From surgery until hospital discharge, up to 48 hours
Postoperative Nausea and Vomiting (PONV)
Time frame: Assessed once, on postoperative day 1 (within the first 24 postoperative hours)
First-Night Control Perception
Time frame: Postoperative Day 1
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 30 Sep 2026.
- Background: PubMed 36161615Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
- Individual participant dataSharing planned: No. No individual participant data sharing plan is currently available for this study.
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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.
Burcu Demir Gokmen principal investigator
Agri Ibrahim Cecen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led First-Night Preparation Intervention in people with Thyroidectomy, run by Volkan Gokmen 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 4 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 30 Sep 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?
Quality of Recovery (QoR-15T Score) (time frame: Postoperative Day 1 (within 24 hours after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07849946, which also lists 1 linked publication.
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 30 Sep 2026.