SurgeryNCT05057585
The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients Undergoing Major Surgery
A study testing Turning in bed, arm and leg exercises in people with Surgery and Anxiety, run by Gurkan Kapikiran at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of bed exercises on pain, anxiety, early ambulation and mobilization in major surgery patients were aimed. The research was experimental and a total of 120 patients participated. Data were collected using an information form, anxiety scale, and pain scale. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Turning in bed, arm and leg exercises
- 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
- 15 Jan 2020to 10 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Ability to communicate verbally and not having a cognitive problem,
- Defining pain severity of 4 and above,
- Willing to participate in the study,
- Having undergone major surgery.
Who cannot join
- The absence of open wounds and cellulite in the area to be applied,
- The absence of thrombophlebitis,
- The absence of deep vein thrombosis,
- The absence of inflammatory diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients
In this study, the effects of bed exercises on pain, anxiety, early ambulation and mobilization in major surgery patients were aimed. The research was experimental and a total of 120 patients participated. Data were collected using an information form, anxiety scale, and pain scale. Exercise was applied to the patients in the experimental group (15 minutes) and no intervention was applied to the control group. Descriptive statistics, correlation tests and t-test were used. Cronbach's alpha coefficients were checked for the scales.
Read the detailed description
Major surgery are operations that can cause morbidity and mortality. Worldwide, approximately 230 million major surgical interventions are performed each year. Major surgery is a stressful experience and causes life-threatening fear and anxiety by increasing the level of anxiety. The most important of these fears is the pain that may occur after surgery. More than 75% of patients who experience postoperative pain in the Western world report that they experience moderate to severe pain. In our country, this rate is over 90%. If pain management is inadequate, patients' quality of life is adversely affected. In pain management, nurses can use non-pharmacological methods such as massage and exercise in addition to pharmacological applications.
Leg-arm exercises done in bed are aimed at protecting the muscle strength of individuals. Turning in bed, leg-arm exercises, raising the heels and feet, inverting the arms, moving from right to left, reverse arm and leg movements are performed. Also 6-8. Early ambulation is recommended. If these applications are made, early recovery and rapid discharge can be achieved. Since pain and anxiety delay early recovery in patients undergoing major surgery, effective pain management is very important. In this study, we aimed to examine the effects of in-bed exercises on anxiety and pain in patients undergoing major surgery.
- Being tested
- Turning in bed, arm and leg exercises
- Keywords
- Anxiety, Early ambulation, Bed exercise, Major surgery, Mobilization
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turning in bed, arm and leg exercisesBehavioural
Exercises (arm and leg exercises, turning in bed) were applied only to the experimental group. It was applied for 15 minutes 12-24 hours before the operation.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Each patient in the experimental group was given in-bed exercises for 15 minutes. An anxiety questionnaire was asked to both the experimental and control groups. It was expected that both the experimental and control group patients would be stable in the postoperative period. The same exercises were applied again for 15 minutes to the patients who were stable after the surgery. Then the patients were made to take steps around the bed. Pain levels were measured. Receives: Behavioral: Turning in bed, arm and leg exercises |
| No treatment group | No intervention | Apart from clinical protocols, no application was made in patient follow-up. Anxiety scale was filled and pain level was evaluated. Pain and anxiety scales were refilled within the same period without any application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
It is the form in which the patient's anxiety is measured. The expected value in the scale is between 0 and 50 points. As the Scale Score increases, the level of anxiety also increases.
Measured: 0-15 minutes
Pain level
It is a measure of pain level. Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
Measured: 0-15 minutes
Early Ambulation
It is the form in which the postoperative mobilization times are measured.
Measured: 0-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start15 Jan 2020
- Primary completion30 May 2020
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Model description
- This research was conducted as a prospective and experimental study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gurkan Kapikiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gurkan Kapikiran, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057585
- Sponsor's protocol ID
- 2020/33
- Status last verified
- Mar 2022
- First submitted
- 3 Sep 2021
- Last updated
- 29 Mar 2022
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients
- ClinicalTrials.gov ID
- NCT05057585
- Acronym / sponsor ID
- 2020/33
- Keywords
- Anxiety, Early ambulation, Bed exercise, Major surgery, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gurkan KapikiranUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 27 Sep 2021 (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.
In this study, the effects of bed exercises on pain, anxiety, early ambulation and mobilization in major surgery patients were aimed. The research was experimental and a total of 120 patients participated. Data were collected using an information form, anxiety scale, and pain scale. Exercise was applied to the patients in the experimental group (15 minutes) and no intervention was applied to the control group. Descriptive statistics, correlation tests and t-test were used. Cronbach's alpha coefficients were checked for the scales.
Detailed description
Major surgery are operations that can cause morbidity and mortality. Worldwide, approximately 230 million major surgical interventions are performed each year. Major surgery is a stressful experience and causes life-threatening fear and anxiety by increasing the level of anxiety. The most important of these fears is the pain that may occur after surgery. More than 75% of patients who experience postoperative pain in the Western world report that they experience moderate to severe pain. In our country, this rate is over 90%. If pain management is inadequate, patients' quality of life is adversely affected. In pain management, nurses can use non-pharmacological methods such as massage and exercise in addition to pharmacological applications.
Leg-arm exercises done in bed are aimed at protecting the muscle strength of individuals. Turning in bed, leg-arm exercises, raising the heels and feet, inverting the arms, moving from right to left, reverse arm and leg movements are performed. Also 6-8. Early ambulation is recommended. If these applications are made, early recovery and rapid discharge can be achieved. Since pain and anxiety delay early recovery in patients undergoing major surgery, effective pain management is very important. In this study, we aimed to examine the effects of in-bed exercises on anxiety and pain in patients undergoing major surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This research was conducted as a prospective and experimental study
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Turning in bed, arm and leg exercisesEach patient in the experimental group was given in-bed exercises for 15 minutes. An anxiety questionnaire was asked to both the experimental and control groups. It was expected that both the experimental and control group patients would be stable in the postoperative period. The same exercises were applied again for 15 minutes to the patients who were stable after the surgery. Then the patients were made to take steps around the bed. Pain levels were measured. |
| No treatment group | No intervention | –Apart from clinical protocols, no application was made in patient follow-up. Anxiety scale was filled and pain level was evaluated. Pain and anxiety scales were refilled within the same period without any application. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older,
- Ability to communicate verbally and not having a cognitive problem,
- Defining pain severity of 4 and above,
- Willing to participate in the study,
- Having undergone major surgery.
Key exclusion criteria (4 listed)
- The absence of open wounds and cellulite in the area to be applied,
- The absence of thrombophlebitis,
- The absence of deep vein thrombosis,
- The absence of inflammatory diseases.
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 |
|---|---|---|
| Turning in bed, arm and leg exercisesExercises (arm and leg exercises, turning in bed) were applied only to the experimental group. It was applied for 15 minutes 12-24 hours before the operation. | Behavioural | Exercise group |
Primary outcome
Anxiety
Time frame: 0-15 minutes
It is the form in which the patient's anxiety is measured. The expected value in the scale is between 0 and 50 points. As the Scale Score increases, the level of anxiety also increases.
Pain level
Time frame: 0-15 minutes
It is a measure of pain level. Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
Early Ambulation
Time frame: 0-15 minutes
It is the form in which the postoperative mobilization times are measured.
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 29 Mar 2022.
- 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 Turning in bed, arm and leg exercises in people with Surgery and Anxiety, run by Gurkan Kapikiran 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 5 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 29 Mar 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?
Anxiety (time frame: 0-15 minutes). 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 29 Mar 2022.