- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369544
The Effect of Preoperative Hugging With Family Members on Preoperative Anxiety Levels and Postoperative Pain
The aim of this randomized prospective study is to examine the effect of preoperative family hugging (for at least 20 seconds) on preoperative anxiety levels and postoperative pain.
The main question the study aims to answer is:
- Does preoperative hugging reduce anxiety levels?
- Does preoperative hugging reduce postoperative pain scores? Anxiety and pain scores will be evaluated between patients who hugged and those who did not hug their family members before surgery, and whether hugging has an effect will be assessed.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Malatya, Turkey (Türkiye)
- Meah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-75 years of age
- ASA 1 and ASA-2 patients
Exclusion Criteria:
- emergency surgery
- malignancy surgery
- neurological and psychiatric illnesses
- chronic pain
- substance abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Hugging group
Patients will be given the opportunity to hug family members for at least 20 seconds before the surgery.
|
Patients will be given the opportunity to hug family members for at least 20 seconds before the surgery.
|
|
Active Comparator: control group
standard practice
|
The standard anesthesia protocol will be followed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Does preoperative hugging reduce anxiety levels?
Time Frame: Preoperative STAI-I and STAI-II anxiety levels of patients will be measured. The relationship between the groups will be evaluated.
|
Preoperative The State-Trait Anxiety Inventory (STAI) I and STAI-II anxiety levels of patients will be measured. This scale gives scores between 20 and 80. The significance of these differences between groups will be evaluated. A higher score indicates a higher anxiety level. The clinically significant score for STAI anxiety level is stated as 39-40. |
Preoperative STAI-I and STAI-II anxiety levels of patients will be measured. The relationship between the groups will be evaluated.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Does preoperative hugging reduce postoperative pain scores?
Time Frame: Postoperative NRS pain scores of patients at 30 minutes and 6 hours will be examined. The relationship between the groups will be evaluated.
|
Postoperative NRS pain scores of patients at 30 minutes and 6 hours will be examined.
It usually ranges from 0 to 10; 0 represents "no pain" and 10 represents "the most severe pain imaginable".
The relationship between the groups will be evaluated.
|
Postoperative NRS pain scores of patients at 30 minutes and 6 hours will be examined. The relationship between the groups will be evaluated.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTÜ-AAD-2025/154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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