AnxietyNCT06117033
The Effect of Video-assisted Mobilisation Training on Mobility, Anxiety and Pain After Coronary Artery Bypass Surgery
A study testing video assisted mobilization training in people with Anxiety and Postoperative Pain, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This study is a Randomized Controlled trial.The aim of this study was to investigate the effect of preoperative routine patient education and video-assisted mobilization training on postoperative mobility, anxiety level and pain in patients undergoing coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Postoperative Pain
- What is being tested?
- video assisted mobilization training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary artery bypass graft surgery,
- Patients aged 18 years and older,
- Patients who can speak Turkish,
- Patients without a diagnosis of cognitive and psychiatric disorders that prevent them from expressing themselves,
- Patients open to communication,
- Patients who volunteered to participate in the study and gave verbal and written informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Routine Patient Education and Video-assisted Mobilization Training on Postoperative Mobillity, Anxiety Level and Pain in Patients Who Will Undergo Coronary Artery Bypass Graft Surgery
This study is a Randomized Controlled trial.The aim of this study was to investigate the effect of preoperative routine patient education and video-assisted mobilization training on postoperative mobility, anxiety level and pain in patients undergoing coronary artery bypass graft surgery.
Hypotheses of the study:
Read more
H1= Routine patient education and video-assisted mobilization training have an effect on postoperative anxiety level in patients undergoing coronary artery bypass graft surgery.
H2= Routine patient education and video-assisted mobilization training have an effect on postoperative mobility in patients undergoing coronary artery bypass graft surgery.
H3= Routine patient education and video-assisted mobilization training have an effect on postoperative pain in patients undergoing coronary artery bypass graft surgery.
Read the detailed description
This study is a Randomized Controlled trial. The study consists of 80 patients, 40 control and 40 study group. Patients in the experimental group who underwent coronary artery bypass graft surgery completed the "State Trait Anxiety Scale" in the preoperative period.
Then, video-assisted mobilization training was given together with routine patient training.After the patient underwent surgery, the "State Trait Anxiety Scale" was completed again before the first mobilization.After the first mobilization, "Patient Mobility Scale" and "Observer Mobility Scale" were completed."State Trait Anxiety Scale" was used again on the 2nd postoperative day before mobilization."Patient Mobility Scale" and "Observer Mobility Scale" were used after the patient was mobilized.
Patients in the control group who underwent coronary artery bypass graft surgery completed the "State Trait Anxiety Scale" in the preoperative period.Routine patient education was then given.After the patient underwent surgery, the "State Trait Anxiety Scale" was completed again before the first mobilization.After the first mobilization, "Patient Mobility Scale" and "Observer Mobility Scale" were completed. The "State Trait Anxiety Scale" was used again before mobilization on the 2nd postoperative day.After the patient was mobilized, "Patient Mobility Scale" and "Observer Mobility Scale" were used.
- Conditions
- Anxiety, Postoperative Pain
- Being tested
- video assisted mobilization training
- Keywords
- coronary artery bypass graft, pain, mobility, anxiety
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video assisted mobilization trainingOther
Preoperative video-assisted mobilization training was given to patients undergoing coronary artery bypass graft surgery
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Preoperative routine patient education and video-assisted mobilization training were given to patients undergoing coronary artery bypass graft surgery. Receives: Other: video assisted mobilization training |
| control group | No intervention | Patients in the control group received only routine patient education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative anxiety
The effects of routine patient education and video-assisted mobilization training on postoperative anxiety in patients undergoing coronary artery bypass graft surgery were investigated. State Trait Anxiety Scale was used to measure the level of postoperative anxiety. The scale consists of two parts: "State Anxiety Scale" and "Trait Anxiety Scale". The State Anxiety Scale consists of a total of 20 statements. It defines the state anxiety of the individual. The individual is asked to express how he/she feels at a certain moment and under certain conditions, taking into account his/her feelings about that moment. There are 20 questions in the trait anxiety scale. It is asked to measure an individual's trait anxiety. The trait anxiety scale includes questions about how the individual usually feels. The total score value obtained from each scale is between 20-80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.
Measured: up to six months
postoperative mobility
The effects of routine patient education and video-assisted mobilization training on postoperative mobility in patients undergoing coronary artery bypass graft surgery were investigated.
Patient Mobility Scale and Observer Mobility were used to measure the level of postoperative mobility. The patient mobility and observer mobility scale consists of two parts: "Patient Mobility" and "Observer Mobility".
The Patient Mobility Scale includes questions to measure the difficulty and pain experienced by the individual during activities such as turning from one side to the other in bed, sitting on the edge of the bed, standing up on the edge of the bed and walking in the patient room. It was evaluated using a 15 cm visual analog and verbal statements were included at the bottom.
The Observer Mobility Scale consists of the assessment of 4 postoperative activities including turning, sitting, standing and walking. The patient's dependence or independence on the nurse is calculated.
Measured: up to six months
postoperative pain
The effects of routine patient education and video-assisted mobilization training on postoperative mobility in patients undergoing coronary artery bypass graft surgery were investigated.
Patient Mobility Scale and Observer Mobility were used to measure the level of postoperative mobility. The patient mobility and observer mobility scale consists of two parts: "Patient Mobility" and "Observer Mobility".
The Patient Mobility Scale includes questions to measure the difficulty and pain experienced by the individual during activities such as turning from one side to the other in bed, sitting on the edge of the bed, standing up on the edge of the bed and walking in the patient room. It was evaluated using a 15 cm visual analog and verbal statements were included at the bottom.
The Observer Mobility Scale consists of the assessment of 4 postoperative activities including turning, sitting, standing and walking. The patient's dependence or independence on the nurse is calculated.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start15 Mar 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Tosun, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117033
- Sponsor's protocol ID
- MTosun
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Routine Patient Education and Video-assisted Mobilization Training on Postoperative Mobillity, Anxiety Level and Pain in Patients Who Will Undergo Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06117033
- Acronym / sponsor ID
- MTosun
- Conditions
- Anxiety, Postoperative Pain
- Keywords
- coronary artery bypass graft, pain, mobility, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 3 Nov 2023 (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 is a Randomized Controlled trial.The aim of this study was to investigate the effect of preoperative routine patient education and video-assisted mobilization training on postoperative mobility, anxiety level and pain in patients undergoing coronary artery bypass graft surgery.
Hypotheses of the study:
H1= Routine patient education and video-assisted mobilization training have an effect on postoperative anxiety level in patients undergoing coronary artery bypass graft surgery.
H2= Routine patient education and video-assisted mobilization training have an effect on postoperative mobility in patients undergoing coronary artery bypass graft surgery.
H3= Routine patient education and video-assisted mobilization training have an effect on postoperative pain in patients undergoing coronary artery bypass graft surgery.
Detailed description
This study is a Randomized Controlled trial. The study consists of 80 patients, 40 control and 40 study group. Patients in the experimental group who underwent coronary artery bypass graft surgery completed the "State Trait Anxiety Scale" in the preoperative period.
Then, video-assisted mobilization training was given together with routine patient training.After the patient underwent surgery, the "State Trait Anxiety Scale" was completed again before the first mobilization.After the first mobilization, "Patient Mobility Scale" and "Observer Mobility Scale" were completed."State Trait Anxiety Scale" was used again on the 2nd postoperative day before mobilization."Patient Mobility Scale" and "Observer Mobility Scale" were used after the patient was mobilized.
Patients in the control group who underwent coronary artery bypass graft surgery completed the "State Trait Anxiety Scale" in the preoperative period.Routine patient education was then given.After the patient underwent surgery, the "State Trait Anxiety Scale" was completed again before the first mobilization.After the first mobilization, "Patient Mobility Scale" and "Observer Mobility Scale" were completed. The "State Trait Anxiety Scale" was used again before mobilization on the 2nd postoperative day.After the patient was mobilized, "Patient Mobility Scale" and "Observer Mobility Scale" were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: video assisted mobilization trainingPreoperative routine patient education and video-assisted mobilization training were given to patients undergoing coronary artery bypass graft surgery. |
| control group | No intervention | –Patients in the control group received only routine patient education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing coronary artery bypass graft surgery,
- Patients aged 18 years and older,
- Patients who can speak Turkish,
- Patients without a diagnosis of cognitive and psychiatric disorders that prevent them from expressing themselves,
- Patients open to communication,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| video assisted mobilization trainingPreoperative video-assisted mobilization training was given to patients undergoing coronary artery bypass graft surgery | Other | experimental group |
Primary outcome
postoperative anxiety
Time frame: up to six months
The effects of routine patient education and video-assisted mobilization training on postoperative anxiety in patients undergoing coronary artery bypass graft surgery were investigated. State Trait Anxiety Scale was used to measure the level of postoperative anxiety. The scale consists of two parts: "State Anxiety Scale" and "Trait Anxiety Scale". The State Anxiety Scale consists of a total of 20 statements. It defines the state anxiety of the individual. The individual is asked to express how he/she feels at a certain moment and under certain conditions, taking into account his/her feelings about that moment. There are 20 questions in the trait anxiety scale. It is asked to measure an individual's trait anxiety. The trait anxiety scale includes questions about how the individual usually feels. The total score value obtained from each scale is between 20-80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.
postoperative mobility
Time frame: up to six months
The effects of routine patient education and video-assisted mobilization training on postoperative mobility in patients undergoing coronary artery bypass graft surgery were investigated. Patient Mobility Scale and Observer Mobility were used to measure the level of postoperative mobility. The patient mobility and observer mobility scale consists of two parts: "Patient Mobility" and "Observer Mobility". The Patient Mobility Scale includes questions to measure the difficulty and pain experienced by the individual during activities such as turning from one side to the other in bed, sitting on the edge of the bed, standing up on the edge of the bed and walking in the patient room. It was evaluated using a 15 cm visual analog and verbal statements were included at the bottom. The Observer Mobility Scale consists of the assessment of 4 postoperative activities including turning, sitting, standing and walking. The patient's dependence or independence on the nurse is calculated.
postoperative pain
Time frame: up to six months
The effects of routine patient education and video-assisted mobilization training on postoperative mobility in patients undergoing coronary artery bypass graft surgery were investigated. Patient Mobility Scale and Observer Mobility were used to measure the level of postoperative mobility. The patient mobility and observer mobility scale consists of two parts: "Patient Mobility" and "Observer Mobility". The Patient Mobility Scale includes questions to measure the difficulty and pain experienced by the individual during activities such as turning from one side to the other in bed, sitting on the edge of the bed, standing up on the edge of the bed and walking in the patient room. It was evaluated using a 15 cm visual analog and verbal statements were included at the bottom. The Observer Mobility Scale consists of the assessment of 4 postoperative activities including turning, sitting, standing and walking. The patient's dependence or independence on the nurse is calculated.
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 Nov 2023.
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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 video assisted mobilization training in people with Anxiety and Postoperative Pain, run by Namik Kemal 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 6 inclusion and 1 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 Nov 2023. 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?
postoperative anxiety (time frame: up to six months). The study lists 3 primary outcomes in all. 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 Nov 2023.