HealthyNCT04610151
The Effects of Guided Imagery on Postoperative Pain Management
A study testing guided imagery in people with Healthy and Nursing Caries, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effects of guided imagery on postoperative pain management. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Nursing Caries
- What is being tested?
- guided imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients at and over the age of 18
- Patients who were able to speak Turkish
- Patients who received spinal anesthesia
Who cannot join
- Patients who had not previously used guided imagery
- Patients any disease that could cause pain outside the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Guided Imagery on Postoperative Pain Management: A Randomized Controlled Trial
This study was conducted to determine the effects of guided imagery on postoperative pain management.
Read the detailed description
The sample of the study consisted of 60 patients (30 in the experiment and 30 in the control groups) undergoing lower extremity operations at the orthopedics clinics of the Kahramanmaras Necip Fazil City Hospital. The study was conducted between April and September 2018.
- Conditions
- Healthy, Nursing Caries
- Being tested
- guided imagery
- Keywords
- Patient, Postoperative, Pain, Visual Analogue Scale, Guided Imagery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided imageryOther
Guided Imagery CD: A guided imagery CD was prepared by a web designer with the recommendations of the researcher to include relaxing, soft and slow-paced, mixed nature sounds and photographs towards reducing pain in lower extremity surgical operation patients. The directives used for guidance, the audio recordings created as a result of literature review and the video lasted for 13 minutes (
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery | Experimental | Guided Imagery Intervention:The pretest data of the patients with a pain score of 4 or higher according to VAS were collected. Afterwards, the experiment group patients were applied guided imagery. Receives: Other: guided imagery |
| No-Reflexology Application , control group. | No intervention | No intervention was applied on the control group patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A mean total score on the Visual Analogue Scale (VAS)
A mean total score on the VAS of four and above indicates postoperative pain.
Measured: first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Apr 2018
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- The study was conducted with patients undergoing lower extremity operations between April 2018 and May 2019 at the Necip Fazıl City Hospital (Kahramanmaraş, Turkey) as a pretest-posttest study with a quasi-experimental design and a control group.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla ZENGİN AYDIN, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610151
- Sponsor's protocol ID
- LZA2018/5
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Guided Imagery on Postoperative Pain Management: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04610151
- Acronym / sponsor ID
- LZA2018/5
- Conditions
- Healthy, Nursing Caries
- Keywords
- Patient, Postoperative, Pain, Visual Analogue Scale, Guided Imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 30 Oct 2020 (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 was conducted to determine the effects of guided imagery on postoperative pain management.
Detailed description
The sample of the study consisted of 60 patients (30 in the experiment and 30 in the control groups) undergoing lower extremity operations at the orthopedics clinics of the Kahramanmaras Necip Fazil City Hospital. The study was conducted between April and September 2018.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The study was conducted with patients undergoing lower extremity operations between April 2018 and May 2019 at the Necip Fazıl City Hospital (Kahramanmaraş, Turkey) as a pretest-posttest study with a quasi-experimental design and a control group.
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Other: guided imageryGuided Imagery Intervention:The pretest data of the patients with a pain score of 4 or higher according to VAS were collected. Afterwards, the experiment group patients were applied guided imagery. |
| No-Reflexology Application , control group. | No intervention | –No intervention was applied on the control group patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients at and over the age of 18
- Patients who were able to speak Turkish
- Patients who received spinal anesthesia
Key exclusion criteria (2 listed)
- Patients who had not previously used guided imagery
- Patients any disease that could cause pain outside the surgery
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 |
|---|---|---|
| guided imageryGuided Imagery CD: A guided imagery CD was prepared by a web designer with the recommendations of the researcher to include relaxing, soft and slow-paced, mixed nature sounds and photographs towards reducing pain in lower extremity surgical operation patients. The directives used for guidance, the audio recordings created as a result of literature review and the video lasted for 13 minutes ( | Other | Guided Imagery |
Primary outcome
A mean total score on the Visual Analogue Scale (VAS)
Time frame: first week
A mean total score on the VAS of four and above indicates postoperative 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 30 Oct 2020.
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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 guided imagery in people with Healthy and Nursing Caries, run by Dicle University 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 3 inclusion and 2 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 30 Oct 2020. 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?
A mean total score on the Visual Analogue Scale (VAS) (time frame: first week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2020.