PainNCT05425849
Pain Due to Peripheral Intravenous Catheter Insertion
A study testing rose oil aromatherapy in people with Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effectiveness of rose oil aromatherapy and hand-holding in reducing pain associated with peripheral intravenous catheters (PIVCs) insertion. Study Hypothesis: H0-1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- rose oil aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2021to 10 Sep 2021
- 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 voluntarily accepted to participate in the study,
- aged between 18-65,
- Turkish literate,
- PIVC placement planned,
- no hematoma, ecchymosis, scar and sensory change in the antecubital region,
- suitable for PIVC insertion with a 20 gauge (pink) catheter in the antecubital region,
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- who did not take analgesic drugs for 24 hours and were accompanied by a member of the patient's family (spouse or child).
- patients with an Enhanced Adult DIVA (EA-DIVA) score below 8 for PIVC placement in a single intervention,
- the STAI score below 40
Who cannot join
- sensitive to smell and had problems in smelling,
- patients with epilepsy, asthma diagnosis,
- patients with a history of allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Rose Oil Aromatherapy and Hand-Holding on Pain Due to Peripheral Intravenous Catheter Insertion: A Mixed Method Study
This study aimed to evaluate the effectiveness of rose oil aromatherapy and hand-holding in reducing pain associated with peripheral intravenous catheters (PIVCs) insertion.
Study Hypothesis:
H0-1. The application of rose oil aromatherapy during the PIVC insertion procedure does not reduce the pain associated with the procedure.
H0-2. During the PIVC insertion procedure, the patient's family holding the patient's hand does not reduce the pain associated with the procedure.
- Conditions
- Pain
- Being tested
- rose oil aromatherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rose oil aromatherapyOther
Also called handholding
Aromatherapy refers to the medicinal or therapeutic use of essential oils absorbed through the skin or the olfactory system. The positive effects of social support, such as hand-holding, on anxiety and pain have been described
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | No attempt was made to reduce pain in the patients in the control group. Standard PIVC insertion procedure was applied. |
| rose oil group | Experimental | After the patients in the rose aromatherapy group were placed in a sitting position, a face mask with 1-2 drops of rose oil was placed on the nose area. Then, the standard PIVC insertion procedure was applied. After the procedure, the patient's rose-scented mask was replaced with a standard mask. Receives: Other: rose oil aromatherapy |
| hand holding group | Experimental | After the patients in the hand-holding group were placed in a sitting position, the patient's family was asked to hold the patient's hand and not let it go until the procedure was over. Standard PIVC insertion procedure was applied. Receives: Other: rose oil aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Numeric Rating Scale was used. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
Measured: 1 minute-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start10 Apr 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
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.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tulay Basak, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425849
- Sponsor's protocol ID
- 394
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basak T, Demirtas A, Duman S. The effect of rose oil aromatherapy and hand-holding on pain due to peripheral intravenous catheter insertion. Explore (NY). 2024 Jan-Feb;20(1):62-69. doi: 10.1016/j.explore.2023.06.002. Epub 2023 Jun 7.
PubMed 37301653
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rose Oil Aromatherapy and Hand-Holding on Pain Due to Peripheral Intravenous Catheter Insertion: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT05425849
- Acronym / sponsor ID
- 394
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 21 Jun 2022 (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.
This study aimed to evaluate the effectiveness of rose oil aromatherapy and hand-holding in reducing pain associated with peripheral intravenous catheters (PIVCs) insertion.
Study Hypothesis:
H0-1. The application of rose oil aromatherapy during the PIVC insertion procedure does not reduce the pain associated with the procedure.
H0-2. During the PIVC insertion procedure, the patient's family holding the patient's hand does not reduce the pain associated with the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –No attempt was made to reduce pain in the patients in the control group. Standard PIVC insertion procedure was applied. |
| rose oil group | Experimental | Other: rose oil aromatherapyAfter the patients in the rose aromatherapy group were placed in a sitting position, a face mask with 1-2 drops of rose oil was placed on the nose area. Then, the standard PIVC insertion procedure was applied. After the procedure, the patient's rose-scented mask was replaced with a standard mask. |
| hand holding group | Experimental | Other: rose oil aromatherapyAfter the patients in the hand-holding group were placed in a sitting position, the patient's family was asked to hold the patient's hand and not let it go until the procedure was over. Standard PIVC insertion procedure was applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patients voluntarily accepted to participate in the study,
- aged between 18-65,
- Turkish literate,
- PIVC placement planned,
- no hematoma, ecchymosis, scar and sensory change in the antecubital region,
Key exclusion criteria (3 listed)
- sensitive to smell and had problems in smelling,
- patients with epilepsy, asthma diagnosis,
- patients with a history of allergy
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 |
|---|---|---|
| rose oil aromatherapyAlso: handholdingAromatherapy refers to the medicinal or therapeutic use of essential oils absorbed through the skin or the olfactory system. The positive effects of social support, such as hand-holding, on anxiety and pain have been described | Other | hand holding group, rose oil group |
Primary outcome
Pain Score
Time frame: 1 minute-10 minutes
Numeric Rating Scale was used. The scale is composed of 0 (no pain at all) to 10 (worst imaginable 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 24 Jun 2022.
- Derived from this study: PubMed 37301653Basak T, Demirtas A, Duman S. The effect of rose oil aromatherapy and hand-holding on pain due to peripheral intravenous catheter insertion. Explore (NY). 2024 Jan-Feb;20(1):62-69. doi: 10.1016/j.explore.2023.06.002. Epub 2023 Jun 7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rose oil aromatherapy in people with Pain, run by Saglik Bilimleri Universitesi 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 9 inclusion and 3 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 24 Jun 2022. 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 Score (time frame: 1 minute-10 minutes). 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 NCT05425849, 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 24 Jun 2022.