SurgeryNCT06531057
Determination Of Factors Affecting Mobility
An observational study of Surgery, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
This descriptive study was conducted to determine the factors affecting mobility in patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgery
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 20 Dec 2019
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of the study consisted of 236 patients who underwent cholecystectomy, appendectomy, hernia surgery and bariatric surgery in the general surgery clinic of the specified hospital on the dates of data collection. Among these patients, 152 patients who met the sampling criteria and volunteered to participate in the study were included in the sample.
Who may be able to join
- • had no chronic pain or no visual or hearing impairment,
- were 18 years of age or older,
- were conscious after surgery,
- had walked for the first time in the patient room after the surgery according to the clinical routine,
- were voluntary to participate in the study.
Who cannot join
- Fifty four patients who did not speak Turkish and 28 patients who failed to walk for the first time after surgery were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination Of Factors Affecting Mobility In Patients Undergoing Abdominal Surgery
This descriptive study was conducted to determine the factors affecting mobility in patients undergoing abdominal surgery.
Read the detailed description
Surgical factors that may affect the mobility of patients undergoing abdominal surgery should be examined, as well as individual characteristics and characteristics related to the postoperative period. If nurses know about the factors that may affect the patient's mobility after surgery, this may be helpful in effectively managing these factors in clinics and encouraging the patient to be more active.
This study was conducted to determine the mobility of patients who underwent abdominal surgery in the early postoperative period and the factors affecting mobility.
- Conditions
- Surgery
- Keywords
- postoperative care, Mobilization, Surgical Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cross sectional | The population of the study consisted of 236 patients who underwent cholecystectomy, appendectomy, hernia surgery and bariatric surgery in the general surgery clinic of the specified hospital on the dates of data collection. Among these patients, 152 patients who met the sampling criteria and volunteered to participate in the study were included in the sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Mobility Scale
Through the patient mobility scale, the observer assesses the pain and difficulty experienced while exercising four activities in the postoperative period: "turning from one side of the bed to the other", "sitting on the edge of the bed", "standing up on the edge of the bed" and "walking in the patient room". The severity of perceived pain was rated on a five-point Likert-type scale anchored at "no pain(1)", " a little pain (2)", "moderate pain (3)", "a lot of pain (4)", "the worst pain (5)"; and the degree of difficulty was rated on a five-point Likert-type scale anchored at "very easy (1), easy (2), a bit difficult (3), difficult (4), and very difficult (5)" to determine how much pain and difficulty they felt. The pain and difficulty scores for each movement are summed up separately. The minimum and maximum scores for pain and difficulty are 4 and 20, respectively. A higher score means an increase in the degree of pain and difficulty of the movement.
Measured: at day 1
Secondary outcomes (2)
Observer Mobility Scale
This scale assesses the extent to which patients are dependent/independent during the movements, and the observer measures blood pressure, pulse rate and respiratory rate two minutes before and two minutes after the movement. Patients are assessed on a 1-5-point scale for their dependence while doing the movements. One point on the scale means that the patient can move independently, while five points means that the patient is unable to move despite verbal warnings and physical assistance. The total score of the scale is obtained by summing the scores for the four movements: "turning from one side of the bed to the other", "sitting on the edge of the bed", "standing up on the edge of the bed" and "walking in the patient room". The minimum and maximum scores of the scale are 4 and 20, respectively. The higher the score, the greater the dependency during the movement
Measured: at day 1
Questionnaire for Factors Affecting Movement
The form included 17 questions on post-operative nausea-vomiting, sleep duration, presence of visitors, feeling weak, fear of falling, needing someone while moving, presence of someone to support while moving, fear of wounds to dehiscence while moving, suffering from stress due to surgery, use of the medical devices, pain, uncomfortable clothes and lack of information on how to move.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Sep 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Karaaslan, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531057
- Sponsor's protocol ID
- SankoU-Nursing-EK-003
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Of Factors Affecting Mobility In Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06531057
- Acronym / sponsor ID
- SankoU-Nursing-EK-003
- Conditions
- Surgery
- Keywords
- postoperative care, Mobilization, Surgical Nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 31 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.
This descriptive study was conducted to determine the factors affecting mobility in patients undergoing abdominal surgery.
Detailed description
Surgical factors that may affect the mobility of patients undergoing abdominal surgery should be examined, as well as individual characteristics and characteristics related to the postoperative period. If nurses know about the factors that may affect the patient's mobility after surgery, this may be helpful in effectively managing these factors in clinics and encouraging the patient to be more active.
This study was conducted to determine the mobility of patients who underwent abdominal surgery in the early postoperative period and the factors affecting mobility.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cross sectional | – | –The population of the study consisted of 236 patients who underwent cholecystectomy, appendectomy, hernia surgery and bariatric surgery in the general surgery clinic of the specified hospital on the dates of data collection. Among these patients, 152 patients who met the sampling criteria and volunteered to participate in the study were included in the sample. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study consisted of 236 patients who underwent cholecystectomy, appendectomy, hernia surgery and bariatric surgery in the general surgery clinic of the specified hospital on the dates of data collection. Among these patients, 152 patients who met the sampling criteria and volunteered to participate in the study were included in the sample.
Key inclusion criteria (5 listed)
- • had no chronic pain or no visual or hearing impairment,
Key exclusion criteria (1 listed)
- Fifty four patients who did not speak Turkish and 28 patients who failed to walk for the first time after surgery were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Mobility Scale
Time frame: at day 1
Through the patient mobility scale, the observer assesses the pain and difficulty experienced while exercising four activities in the postoperative period: "turning from one side of the bed to the other", "sitting on the edge of the bed", "standing up on the edge of the bed" and "walking in the patient room". The severity of perceived pain was rated on a five-point Likert-type scale anchored at "no pain(1)", " a little pain (2)", "moderate pain (3)", "a lot of pain (4)", "the worst pain (5)"; and the degree of difficulty was rated on a five-point Likert-type scale anchored at "very easy (1), easy (2), a bit difficult (3), difficult (4), and very difficult (5)" to determine how much pain and difficulty they felt. The pain and difficulty scores for each movement are summed up separately. The minimum and maximum scores for pain and difficulty are 4 and 20, respectively. A higher score means an increase in the degree of pain and difficulty of the movement.
2 secondary outcomes
Observer Mobility Scale
Time frame: at day 1
Questionnaire for Factors Affecting Movement
Time frame: at day 1
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 5 Aug 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?
An observational study of Surgery, run by Sanko 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 5 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 5 Aug 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?
Patient Mobility Scale (time frame: at day 1). 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 5 Aug 2024.