NCT Number: NCT03420911
Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department
The aim of this study is to determine the level of pain and anxiety in patients who present to the emergency department with acute pain, and to investigate the effect of the standard analgesic treatment and an additional anxiolytic treatment on pain and anxiety.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
After triage, each acute pain patient who qualified for the study was asked for consent. Written informed consent was obtained from all patients who were eligible for the study. After obtaining written informed consent, demographic and clinical data were collected and recorded by the attending physician. Our study consisted of two parallel groups. Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program generating an online random number. The control group was given only the analgesic drug dexketoprofen trometamol and the study group was given analgesic plus anxiolytic, the same dose of dexketoprofen trometamol plus midazolam . Both groups received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg, and the midazolam dose was 1 mg. The study was double-blind. Sequenced study medications were prepared by a nurse, and another nurse administered the medications. In patients with an insufficient improvement of pain after 60 minutes, fentanyl 1 mcg/kg ı.v. was administered as a rescue medication.
Pain and anxiety in patients was measured at 0, 30, 60 and 120 minutes using the standard 100 mm horizontal visual analogue scale (VAS). The patient's general anxiety states were measured with the Turkish adopted version of the Hospital Anxiety and Depression Scale (HADS). Patients who have greater than 10 points are assumed anxious (9). The HADS and VAS scores were measured and recorded to the database by the researcher. At the time of discharge, patient satisfaction with treatment was evaluated by asking two questions with the 5-step Likert scale. The questions were, "I am satisfied with the applied treatment", and "I would like the same treatment applied again". Patient answers were, "1-I strongly disagree", "2-I disagree", "3-I am not sure", "4-I agree", and "5-I strongly agree".
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The patients who presented to the emergency department with acute pain
- Who accepted to include the study
- Who were older than 18 years old
Exclusion criteria
- Patients who refused to participate to the study
- History of allergy to any of the study drugs
- Pregnancy
- Younger than 18 years old
- Chronic pain
- Antidepressant or anxiolytic drug use
- Advanced kidney or liver failure
- Use of analgesics within 6 hours before presentation
Treatment and study plan
midazolam
DrugPrimary outcomes
-
the change in pain levels
Time frame: 30 minutes
the change in pain levels between groups on the 100mm visual analogue scale at 0-30th minutes
-
the change in anxiety levels
Time frame: 30 minutes
the change in anxiety levels between groups on the 100mm visual analogue scale at 0-30th minutes
Secondary outcomes
-
the need for rescue treatment
Time frame: 120 minutes
the need for rescue treatment at 60th minute and at 120 th minute
-
the rate of the request for the same treatment
Time frame: 120 minutes
the rate of the request for the same treatment again on the Likert scale
-
the comparison of the pain and anxiety change on the visual analogue scale
Time frame: 120 minutes
the comparison of the pain and anxiety change on the visual analogue scale in patients who have a greater anxiety score.
Sponsors and collaborators
Lead sponsor
Derince Training and Research Hospital
Other
Registry information
Official study title
Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department Due to Acute Pain: a Double Blind, Randomized, Controlled Trial
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Feb 5, 2018
- Registry last updated
- Feb 5, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
The Effect of VR on Pain, Anxiety And Fear During Venipuncture in Children
NCT06527092
Acute Pain, Anxiety
Izmir, Turkey (Türkiye)
View Trial DetailsVirtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy
NCT04721587
Acute Pain, Anxiety
Barcelona, Spain
View Trial DetailsComparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety
NCT07616869
Acute Pain, Anxiety Disorders
Manisa, Yunusemre, Turkey (Türkiye)
View Trial DetailsThe Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety During Blood Sampling Procedures
NCT05904483
Acute Pain, Anxiety
Bartın, Turkey (Türkiye)
View Trial Details