- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259551
Effect of the Palming Technique on Preoperative Anxiety and Hemodynamic Responses in Thyroid Surgery
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
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Van, Turkey (Türkiye), 65080
- Van Yüzüncü Yıl Universitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group P
Patients who received the palm-based technique
|
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 N
Control group without intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Preoperative Anxiety Score (State-Trait Anxiety Inventory - STAI-State)
Time Frame: Baseline (T1) and 15 minutes after intervention (T2)
|
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
Time Frame: Baseline (T1) and 15 minutes after intervention (T2)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nureddin Yuzkat, Yuzuncu Yil University
Publications and helpful links
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
Other Study ID Numbers
- The Palming Technique
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
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