PainNCT03945929
The Peripheral Intravenous Catheterisation
A study testing Distraction in people with Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
Pain management during medical care is considered to be a basic human right and also affects patient satisfaction. In addition, effective management of acute pain contributes to improved patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2018to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who ranked 4 (less urgent) and 5 (non-urgent) based on Canadian Emergency Department Triage
- Patients who had no visual, audial, or lingual disabilities, and no mental disorder.
Who cannot join
- Patients who planned to have PIC insertion and were suitable for having a peripheral intravenous catheter insertion at their antecubital location using 20 Gauge (pink) cannula were eligible.
- Patients who refused to participate in the study,
- Patients who were not eligible for a 20 G peripheral intravenous catheter insertion,
- Patients who could not be inserted a peripheral intravenous catheter at the first time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can We Alleviate Pain Associated With The Peripheral Intravenous Catheterisation By Using Distraction Methods in Adults: A Randomised Controlled Trial
Pain management during medical care is considered to be a basic human right and also affects patient satisfaction. In addition, effective management of acute pain contributes to improved patient outcomes. Patient satisfaction is a subjective state that indicates whether the healthcare provided has met the patient's needs and expectations. Many nurse theorists, including Florence Nightingale, have expressed the importance of providing comfort and relief for patients. In fact, comfort has been a crucial aspect of patient care since Nightingale's days, and has been considered an indispensable constituent of integrated nursing care. Studies to improve comfort may contribute to improving individuals' health outcomes, enforcing health-improvement behaviors, and improving healthcare quality as well as satisfaction and contentment of the individual and the nurse in the process of administering healthcare. In the literature, although the efficacy of various pharmacological methods for reducing pain associated with the insertion of PIC has been evaluated in adults, studies on nonpharmacological methods are limited. However, most of the studies were performed in healthy adults. Easy, inexpensive, and fast methods with unlikely side effects are needed to control pain and distress due to the PIC insertion in adults. Therefore, this study was performed to evaluate the effectiveness of distraction methods.
- Conditions
- Pain
- Being tested
- Distraction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DistractionBehavioural
Distraction-1 Group: Cards containing approximately six optical illusion pictures were shown to the patients and as a method of distraction during the PIC insertion procedure they were asked what they saw in these cards.
Distraction-2 Group: Underwater 3D audial videos were played with visual reality (VR) goggles during PIC insertion until the procedure was completed.
| Study group | Role | What they receive |
|---|---|---|
| Distraction1 group | Experimental | Distraction-1 Group (Cards containing optical illusion pictures) Receives: Behavioral: Distraction |
| Control | No intervention | Control |
| Distraction 2 group | Experimental | Distraction-2 Group Receives: Behavioral: Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Associated With The Peripheral Intravenous Catheterisation
Visual Analog Scale was used to evaluate pain caused by needle insertion. In the Visual Analog Scale of 10 cm length, "0" indicated no pain, and "10" indicated the severest pain.
Measured: 1-2 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start18 Jan 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Demirtas, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- University of Health Sciences Gulhane Faculty of Nursing, Study chair, University of Health Sciences Ankara/Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945929
- Sponsor's protocol ID
- 18/7
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basak T, Duman S, Demirtas A. Distraction-based relief of pain associated with peripheral intravenous catheterisation in adults: a randomised controlled trial. J Clin Nurs. 2020 Mar;29(5-6):770-777. doi: 10.1111/jocn.15131. Epub 2019 Dec 16.
PubMed 31793099
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can We Alleviate Pain Associated With The Peripheral Intravenous Catheterisation By Using Distraction Methods in Adults: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03945929
- Acronym / sponsor ID
- 18/7
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain management during medical care is considered to be a basic human right and also affects patient satisfaction. In addition, effective management of acute pain contributes to improved patient outcomes. Patient satisfaction is a subjective state that indicates whether the healthcare provided has met the patient's needs and expectations. Many nurse theorists, including Florence Nightingale, have expressed the importance of providing comfort and relief for patients. In fact, comfort has been a crucial aspect of patient care since Nightingale's days, and has been considered an indispensable constituent of integrated nursing care. Studies to improve comfort may contribute to improving individuals' health outcomes, enforcing health-improvement behaviors, and improving healthcare quality as well as satisfaction and contentment of the individual and the nurse in the process of administering healthcare. In the literature, although the efficacy of various pharmacological methods for reducing pain associated with the insertion of PIC has been evaluated in adults, studies on nonpharmacological methods are limited. However, most of the studies were performed in healthy adults. Easy, inexpensive, and fast methods with unlikely side effects are needed to control pain and distress due to the PIC insertion in adults. Therefore, this study was performed to evaluate the effectiveness of distraction methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Distraction1 group | Experimental | Behavioral: DistractionDistraction-1 Group (Cards containing optical illusion pictures) |
| Control | No intervention | –Control |
| Distraction 2 group | Experimental | Behavioral: DistractionDistraction-2 Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who ranked 4 (less urgent) and 5 (non-urgent) based on Canadian Emergency Department Triage
- Patients who had no visual, audial, or lingual disabilities, and no mental disorder.
Key exclusion criteria (4 listed)
- Patients who planned to have PIC insertion and were suitable for having a peripheral intravenous catheter insertion at their antecubital location using 20 Gauge (pink) cannula were eligible.
- Patients who refused to participate in the study,
- Patients who were not eligible for a 20 G peripheral intravenous catheter insertion,
- Patients who could not be inserted a peripheral intravenous catheter at the first time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DistractionDistraction-1 Group: Cards containing approximately six optical illusion pictures were shown to the patients and as a method of distraction during the PIC insertion procedure they were asked what they saw in these cards. Distraction-2 Group: Underwater 3D audial videos were played with visual reality (VR) goggles during PIC insertion until the procedure was completed. | Behavioural | Distraction 2 group, Distraction1 group |
Primary outcome
Pain Associated With The Peripheral Intravenous Catheterisation
Time frame: 1-2 minute
Visual Analog Scale was used to evaluate pain caused by needle insertion. In the Visual Analog Scale of 10 cm length, "0" indicated no pain, and "10" indicated the severest pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Derived from this study: PubMed 31793099Basak T, Duman S, Demirtas A. Distraction-based relief of pain associated with peripheral intravenous catheterisation in adults: a randomised controlled trial. J Clin Nurs. 2020 Mar;29(5-6):770-777. doi: 10.1111/jocn.15131. Epub 2019 Dec 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Health Sciences Gulhane Faculty of Nursing study chair
University of Health Sciences Ankara/Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction in people with Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Associated With The Peripheral Intravenous Catheterisation (time frame: 1-2 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.