Nurse-Led First-Night Preparation After Thyroidectomy

NCT07849946 | Completed

• 1 other identifier: AICU-TIROID-IGH-2026
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thyroidectomy

Keywords

Postoperative Care; Sleep Quality; Nursing Intervention; Quality of Recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative Day 1 (within 24 hours after surgery)

Secondary Outcomes (9)

• Sleep Quality (Richards-Campbell Sleep Questionnaire Score)

  Assessed once, on the morning of postoperative day 1, reflecting the first postoperative night

• Postoperative Pain Level (Numeric Rating Scale)

  Assessed once, on postoperative day 1 (within the first 24 postoperative hours)

• Postoperative Sore Throat Severity

  Assessed once, on postoperative day 1 (within the first 24 postoperative hours)

• Postoperative Dysphagia Severity

  Assessed once, on postoperative day 1 (within the first 24 postoperative hours)

• Postoperative Analgesic Consumption

  Cumulative total over the first 24 postoperative hours

Study Arms (2)

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.

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.

Interventions

Nurse-Led First-Night Preparation Intervention BEHAVIORAL

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.

Nurse-Led First-Night Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Emergency (non-elective) thyroidectomy
• Revision or completion thyroidectomy
• Cognitive or communication impairment preventing informed consent or completion of study assessments
• Refusal to participate

Sponsors & Collaborators

• Volkan Gokmen: lead

Study Sites (1)

Agri Training and Research Hospital

Ağrı, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36161615 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Burcu Demir Gokmen

  Agri Ibrahim Cecen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 30, 2026
• Study Start: May 15, 2026
• Primary Completion: August 15, 2026
• Study Completion: August 15, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)