An interventional study of Structured Multicomponent Anxiety-Reduction Protocol in Anxiety, sponsored by Muhammet Okkan. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Muhammet Okkan · Not applicable, Interventional, and Supportive care
Some people feel worried about being awake during hand surgery. In a method called wide-awake local anesthesia no tourniquet (WALANT), the hand is numbed with local anesthetic, and surgery is performed without a tourniquet. This study examined whether extra information and comfort measures could reduce anxiety shortly after surgery compared with usual care.
The study included 120 adults undergoing non-emergency hand surgery at one hospital in Türkiye. Patients were randomly assigned to two groups, with 60 people in each group. Both groups received WALANT surgery.
One group watched a short educational video before surgery, received structured explanations from the surgeon, was asked to take a deep breath as the local anesthetic needle was inserted, and listened to music of their choice during surgery. The other group received usual care, including standard explanations about the surgery and anesthesia.
Patients completed an anxiety questionnaire before the additional measures and again 10 to 30 minutes after surgery. Researchers also assessed pain during local anesthetic injection, patient satisfaction after surgery, and whether patients would choose or recommend WALANT in the future.
This prospective, single-center, parallel-group randomized controlled trial was conducted to evaluate the effect of a structured multicomponent perioperative anxiety-reduction protocol in patients undergoing elective hand surgery under wide-awake local anesthesia no tourniquet (WALANT).
**Randomization and Allocation**
A computer-generated randomization sequence was prepared before participant recruitment. Following written informed consent and enrollment, participants were assigned to the intervention or control group in a 1:1 ratio according to the predetermined sequence. Group allocation was revealed only after enrollment. Randomization was performed regardless of whether surgery had been scheduled in advance or arranged on the day of outpatient assessment.
**Intervention Protocol**
The intervention consisted of four components delivered at different stages of perioperative care.
Before local anesthetic administration, a trained research nurse presented a standardized educational video lasting approximately two minutes. This was followed by structured patient-centered verbal counseling delivered by the operating surgeon. Counseling focused on explaining the WALANT technique, establishing realistic expectations, describing anticipated sensations, encouraging communication, and providing reassurance throughout the procedure.
During local anesthetic injection, patients were instructed to take a deep breath, and needle insertion was synchronized with inspiration as a sensory distraction technique.
Before surgery began, a trained research nurse arranged music according to each patient's preference. Music volume was adjusted to maintain effective verbal communication between the patient and the surgical team.
The control group received routine perioperative care, including the surgeon's usual explanations regarding WALANT anesthesia and the planned surgical procedure, without the additional structured intervention components.
All surgical procedures were performed using the WALANT technique. Both groups received the same local anesthetic preparation consisting of 1% lidocaine with epinephrine (1:100,000), buffered with 8.4% sodium bicarbonate at a ratio of 1 mL per 10 mL of local anesthetic solution.
**Assessments and Statistical Analysis**
Patient-reported assessments were coordinated by a researcher who was not involved in administering the intervention or performing surgery. Postoperative assessments were conducted approximately 10-30 minutes after surgery, before patient discharge.
The primary analysis compared postoperative state anxiety between groups using analysis of covariance (ANCOVA), adjusting for preoperative state anxiety scores. Adjusted between-group differences were estimated using heteroscedasticity-robust standard errors.
Additional analyses examined changes in anxiety scores, injection-related pain, and patient-reported satisfaction. Exploratory analyses assessed associations between baseline anxiety and surgical scheduling status or previous anesthesia history, as well as whether surgical scheduling status modified the intervention effect.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →This is the only study on the registry with Muhammet Okkan as lead sponsor.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm (n=60) received a structured four-component anxiety-reduction protocol in addition to routine perioperative care during WALANT hand surgery. The intervention included: (1) a standardized approximately two-minute educational video presented by a trained research nurse before local anesthetic administration; (2) structured patient-centered verbal counseling by the operating surgeon; (3) deep-breathing instructions with needle insertion synchronized with inspiration during local anesthetic injection; and (4) patient-selected music during surgery, with volume adjusted to maintain communication with the surgical team. All patients underwent surgery using the standard WALANT anesthetic protocol.
Behavioral: Structured Multicomponent Anxiety-Reduction Protocol
Participants in this arm (n=60) received routine perioperative care during WALANT hand surgery, including the operating surgeon's usual verbal explanation of the planned surgical procedure and WALANT anesthesia. The structured multicomponent anxiety-reduction protocol, including additional video education, standardized patient-centered counseling, inspiration-timed injection, and patient-selected music, was not administered. All patients underwent surgery using the same standard WALANT anesthetic protocol as the intervention group.
The structured multicomponent anxiety-reduction protocol was delivered in addition to routine perioperative care and included four components: (1) a standardized approximately 2-minute educational video presented by a trained research nurse before local anesthetic administration; (2) structured patient-centered verbal counseling by the operating surgeon regarding the WALANT procedure, expected sensations, and communication of discomfort; (3) deep-breathing instruction during local anesthetic injection, with needle insertion synchronized with inspiration; and (4) patient-selected music arranged by a trained research nurse before surgery and played during the procedure at a volume allowing communication with the surgical team. The intervention was delivered during a single surgical visit.
Postoperative State Anxiety Score Measured by the State-Trait Anxiety Inventory (STAI-I)
Postoperative state anxiety was assessed using the validated Turkish version of the State form of the State-Trait Anxiety Inventory (STAI-I). The questionnaire consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate greater state anxiety. The primary outcome was the total STAI-I score measured approximately 10-30 minutes after surgery, before patient discharge. Postoperative STAI-I scores were compared between the intervention and control groups using analysis of covariance (ANCOVA), adjusted for preoperative STAI-I scores.
Time frame: 10-30 minutes after completion of surgery, before patient discharge.
Pain During Local Anesthetic Injection Assessed Using a Visual Analogue Scale (VAS)
Injection-related pain was assessed immediately after local anesthetic administration using a 0-10 visual analogue scale (VAS). A score of 0 indicates no pain, while a score of 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity during local anesthetic injection.
Time frame: Immediately after local anesthetic injection, during the surgical visit.
Postoperative Patient Satisfaction Score Assessed Using a 5-Point Rating Scale
Patient satisfaction with the WALANT surgical experience was assessed after completion of surgery using a 5-point rating scale: 1 = not at all satisfied, 2 = slightly satisfied, 3 = moderately satisfied, 4 = very satisfied, and 5 = completely satisfied. Higher scores indicate greater patient satisfaction.
Time frame: Day 1 (postoperative, 10-30 minutes after surgery)
Number of Participants Willing to Undergo WALANT Again
Participants were asked after surgery whether they would choose the WALANT technique again if another surgical procedure were needed. The outcome was the number of participants who answered "Yes" in each study group, indicating willingness to undergo WALANT again.
Time frame: Day 1 (postoperative, 10-30 minutes after surgery)
Number of Participants Willing to Recommend WALANT to Others
Participants were asked after surgery whether they would recommend the Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique to others. Responses were recorded as Yes or No. The outcome was the number of participants who answered "Yes" in each study group, indicating willingness to recommend WALANT to others.
Time frame: Day 1 (postoperative, 10-30 minutes after surgery)
Plan to share: No
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