Using a stress ball during spinal anesthesia to reduce pain and anxiety
The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
This study is testing if using a stress ball can help reduce pain and anxiety for patients having spinal anesthesia during cesarean sections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization Academic / other |
| Locations | 2 sites (Istanbul, Eyup and 1 other locations) |
| Trial ID | NCT06267196 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a stress ball on pain and anxiety levels in patients undergoing spinal anesthesia for cesarean sections. It will be a prospective randomized controlled trial involving patients aged 18 and older categorized as 3 and 4 according to the ASA classification. Participants will be randomly assigned to either use a stress ball during the procedure or not, with pain and anxiety measured before and after the anesthesia. Key metrics such as Visual Analog Scale (VAS) for pain and State Anxiety Inventory (STAI-I) scores will be recorded to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and above undergoing elective cesarean sections categorized as ASA 3 and 4.
Not a fit: Patients under 18, those undergoing emergency cesarean sections, or individuals with bleeding or psychological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and anxiety during spinal anesthesia for cesarean sections.
How similar studies have performed: While the use of stress balls in medical settings is not widely studied, similar interventions have shown promise in reducing anxiety and pain in various clinical scenarios.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 and above. * Patients with cesarean category 3 and 4. Exclusion Criteria: * Patients under the age of 18 * Patients undergoing emergency cesarean section * Patients with bleeding disorders * Individuals with psychological disorders
Where this trial is running
Istanbul, Eyup and 1 other locations
- Özge Sayın Ayan — Istanbul, Eyup, Turkey (Not_yet_recruiting)
- Prof.Dr.Cemil Tascioglu City Hospital — Istanbul, Şişli, Turkey (Recruiting)
Study contacts
- Study coordinator: Özge Sayın Ayan
- Email: ozgesayinayan@gmail.com
- Phone: +905332965628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.