Abdominal PainsingingNCT06486701
Effect of Singing in Abdominal Surgery Patients
A study testing have a sing in people with Abdominal Pain and Anxiety, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Patients who have undergone abdominal surgery are given a prompt in the postoperative period and asked to sing the song they remember. Vital signs, pain and anxiety levels are measured before and after singing. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Abdominal Pain, Anxiety
- What is being tested?
- have a sing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 9 Feb 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominal surgery patiens
- 18 and more than age
Who cannot join
- No abdominal surgery patients
- under 18 age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Singing on Vital Signs, Pain, Anxiety in Abdominal Surgery Patients
Patients who have undergone abdominal surgery are given a prompt in the postoperative period and asked to sing the song they remember. Vital signs, pain and anxiety levels are measured before and after singing.
Read the detailed description
This study is of a randomized controlled type. Patients who have undergone abdominal surgery are divided into experimental and control groups in the early postoperative period. No intervention is made to the control group by the researchers. Vital signs, pain and anxiety levels are measured half an hour apart as pre-test and post-test.
Patients in the experimental group are given a prompt in the postoperative period and asked to sing the song they remember. Pre-test before singing and post-test after singing, vital signs, pain and anxiety levels are measured. It is expected that singing will calm patients, stabilize their vital signs, and reduce anxiety and pain.
- Conditions
- Abdominal Pain, Anxiety
- Being tested
- have a sing
- Keywords
- Signign, Anxiety, Pain, Vital signs, Abdominal surgery patients
- Medical subject headings
- Abdominal Pain, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
have a singBehavioural
Also called Singing
Singing
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Singing Receives: Behavioral: have a sing |
| No intervention | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and anxiety
It will be measure to sing a song after Abdominal Surgery
Measured: total of six month
Secondary outcomes (1)
Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and Anxiety
No intervention, the control group abdominal surgery patients
Measured: total of six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEMRA BÜLBÜLOĞLU, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486701
- Sponsor's protocol ID
- 86.2023fbu
- Acronym
- singing
- Status last verified
- Jun 2024
- First submitted
- 1 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Singing on Vital Signs, Pain, Anxiety in Abdominal Surgery Patients
- ClinicalTrials.gov ID
- NCT06486701
- Acronym / sponsor ID
- singing / 86.2023fbu
- Conditions
- Abdominal Pain, Anxiety
- Keywords
- Signign, Anxiety, Pain, Vital signs, Abdominal surgery patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 3 Jul 2024 (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.
Patients who have undergone abdominal surgery are given a prompt in the postoperative period and asked to sing the song they remember. Vital signs, pain and anxiety levels are measured before and after singing.
Detailed description
This study is of a randomized controlled type. Patients who have undergone abdominal surgery are divided into experimental and control groups in the early postoperative period. No intervention is made to the control group by the researchers. Vital signs, pain and anxiety levels are measured half an hour apart as pre-test and post-test.
Patients in the experimental group are given a prompt in the postoperative period and asked to sing the song they remember. Pre-test before singing and post-test after singing, vital signs, pain and anxiety levels are measured. It is expected that singing will calm patients, stabilize their vital signs, and reduce anxiety and pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: have a singSinging |
| No intervention | No intervention | –Control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Abdominal surgery patiens
- 18 and more than age
Key exclusion criteria (2 listed)
- No abdominal surgery patients
- under 18 age
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 |
|---|---|---|
| have a singAlso: SingingSinging | Behavioural | Experimental |
Primary outcome
Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and anxiety
Time frame: total of six month
It will be measure to sing a song after Abdominal Surgery
1 secondary outcome
Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and Anxiety
Time frame: total of six month
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 3 Jul 2024.
- 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 have a sing in people with Abdominal Pain and Anxiety, run by Istanbul Aydın 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 2 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 3 Jul 2024. 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?
Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and anxiety (time frame: total of six month). 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 3 Jul 2024.