NCT07259551

Brief Summary

Purpose of the Observational Study: The purpose of this observational study was to evaluate the effects of the palmar technique on preoperative anxiety, hemodynamic parameters, and intubation-related hemodynamic responses in patients undergoing thyroidectomy. Primary Research Question: Does the palmar technique applied preoperatively reduce preoperative anxiety and associated hemodynamic changes in thyroidectomy patients? Study Design: Type: Prospective, single-blind, observational study Location: A single-center tertiary care hospital in Turkey Sample: 80 patients aged 18-65, ASA I-II Methods: Patients were divided into two groups using a sealed envelope method: Group P: Patients who received the palm-based technique Group N: Control group without intervention When admitted to the preoperative waiting room (T1), all patients: Baseline vital signs (SpO₂, heart rate, blood pressure) State-Trait Anxiety Inventory (STAI) scores were recorded. Patients in Group P received the palm-based technique; Group N received no intervention. The same parameters were measured again 15 minutes later (T2). After transfer to the operating room, standard monitoring was performed, and hemodynamic data were recorded at the following times: Pre-intubation (T3) 1 min (T4), 3 min (T5), 5 min (T6), and 10 min (T7) after intubation Main Outcome Measures: Changes in preoperative anxiety level Changes in hemodynamic parameters after the palmar technique Sample Size:Total: 80 patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

November 15, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

Hemodynamicsintubationpreoperative anxietyrelaxation techniquesthyroidectomy

Outcome Measures

Primary Outcomes (2)

  • Change in Preoperative Anxiety Score (State-Trait Anxiety Inventory - STAI-State)

    Baseline (TPreoperative anxiety will be assessed using the State-Trait Anxiety Inventory - State (STAI-State) scale (range: 20-80; higher scores indicate higher anxiety). The primary outcome is the change in STAI-State score from baseline (T1) to 15 minutes after the palming technique (T2).1) and 15 minutes after intervention (T2)

    Baseline (T1) and 15 minutes after intervention (T2)

  • Change in Heart Rate

    Change in heart rate (beats per minute) between baseline (T1) and 15 minutes after the palming technique (T2).

    Baseline (T1) and 15 minutes after intervention (T2)

Study Arms (2)

Group P

Patients who received the palm-based technique

Behavioral: Group P

Group N

Control group without intervention

Interventions

Group PBEHAVIORAL

When admitted to the preoperative waiting room (T1), all patients: Baseline vital signs (SpO₂, heart rate, blood pressure) State-Trait Anxiety Inventory (STAI) scores were recorded. Patients in Group P received the palm-based technique; Group N received no intervention. The same parameters were measured again 15 minutes later (T2). After transfer to the operating room, standard monitoring was performed, and hemodynamic data were recorded at the following times: Pre-intubation (T3) 1 min (T4), 3 min (T5), 5 min (T6), and 10 min (T7) after intubation Main Outcome Measures: Changes in preoperative anxiety level Changes in hemodynamic parameters after the palmar technique

Group P

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consisted of adult patients scheduled to undergo thyroidectomy at a tertiary care hospital in Türkiye. A total of 80 patients aged 18-65 years and classified as ASA I-II according to the American Society of Anesthesiologists physical status classification were included. All participants were thoroughly informed about the study procedures and provided written informed consent. Eligible patients had no active psychiatric or neurological disorders, no history of glaucoma, and no prior ophthalmic surgery. Following randomization, patients were assigned to either the palming group (n = 40) or the control group (n = 40).

You may qualify if:

  • Patients aged 18-65 years
  • Patients classified as ASA I-II
  • Patients scheduled for thyroid surgery
  • Patients without a history of glaucoma
  • Patients without active psychiatric or neurological disease
  • Patients who were informed about the study and provided written informed consent

You may not qualify if:

  • Patients with a diagnosed psychiatric disorder
  • Patients using sedatives, antidepressants, or antiepileptic medications
  • Patients with impaired cooperation, comprehension, vision, or hearing
  • Patients with a history of ophthalmic surgery
  • Patients classified as ASA III or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl Universitesi

Van, 65080, Turkey (Türkiye)

Location

Related Publications (1)

  • Wang R, Huang X, Wang Y, Akbari M. Non-pharmacologic Approaches in Preoperative Anxiety, a Comprehensive Review. Front Public Health. 2022 Apr 11;10:854673. doi: 10.3389/fpubh.2022.854673. eCollection 2022.

    PMID: 35480569BACKGROUND

Related Links

Study Officials

  • Nureddin Yuzkat

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 15, 2025

First Posted

December 2, 2025

Study Start

February 1, 2022

Primary Completion

April 15, 2022

Study Completion

May 1, 2022

Last Updated

December 2, 2025

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers due to confidentiality considerations and because data sharing was not included in the informed consent obtained from participants.

Locations