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KinesiophobiaNCT07834554

Kinesiophobia, Postoperative Pain, and Early Mobilization After Elective Abdominal Surgery

An observational study of Kinesiophobia, run by Volkan Gokmen at 2 sites in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study examines the level of kinesiophobia (fear of movement) in patients undergoing elective abdominal surgery and its relationship with postoperative pain severity and early mobilization. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kinesiophobia
What is being tested?
Tampa Scale for Kinesiophobia (TSK)
How many people
120 participants
Where
2 sitesTurkey (Türkiye)
Study dates
Oct 2026to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Adult patients (18 years or older) undergoing elective abdominal surgery under general anesthesia in the General Surgery clinics of Agri Training and Research Hospital and Taksim Training and Research Hospital, who have completed their first postoperative mobilization (typically postoperative day 1).

Who may be able to join

  • Age 18 years or older
  • Having undergone elective (planned) abdominal surgery
  • Having had surgery under general anesthesia
  • ASA (American Society of Anesthesiologists) physical status class I-II
  • Having completed first mobilization on postoperative day 1
  • Able to communicate in Turkish and understand written/verbal directions
  • Conscious and oriented
  • Willing to voluntarily participate and provide informed consent

Who cannot join

  • A known pre-existing walking/movement disorder, balance problem, or orthopedic-neurological disease history
  • Having undergone emergency surgery
  • Being followed in an intensive care unit
  • Having a significant cognitive impairment or communication difficulty that prevents responding to data collection tools
  • Having a visual or hearing impairment that prevents completing the forms/scales
  • Being in a state of heavy postoperative sedation or delirium
  • Having previously been enrolled in the same study
  • Refusing to participate

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Volkan Gokmen, PhD contact

+90 532 739 0938

vgokmen@agri.edu.tr

Turkey (Türkiye)2 sites
  • Agri Training and Research Hospital

    Ağrı

    Burcu Ozen Karabulut, MD, +90 472 215 6363, vgokmen@agri.edu.tr

    Volkan Gokmen, PhD

  • Taksim Training and Research Hospital

    Istanbul

    Volkan Gokmen, PhD, +90 532 739 0938, vgokmen@agri.edu.tr

    Volkan Gokmen, PhD

Other trials in Turkey (Türkiye)

About this study

Official title: Relationship Between Kinesiophobia Level and Postoperative Pain and Early Mobilization in Patients Undergoing Elective Abdominal Surgery: A Descriptive Cross-Sectional Study

This study examines the level of kinesiophobia (fear of movement) in patients undergoing elective abdominal surgery and its relationship with postoperative pain severity and early mobilization. In this descriptive, cross-sectional study, adult patients who have undergone elective abdominal surgery under general anesthesia at two centers (Agri Training and Research Hospital and Taksim Training and Research Hospital) will be assessed after completing their first postoperative mobilization (typically postoperative day 1). Kinesiophobia will be measured with the Turkish version of the Tampa Scale for Kinesiophobia (TSK), postoperative pain with the Numeric Rating Scale (NRS), and early mobilization with a researcher-developed Early Mobilization Record Form (time to first ambulation, standing duration, and first walking distance/duration). The investigators hypothesize that patients' kinesiophobia levels will be positively associated with postoperative pain severity and with delayed/reduced early mobilization, and that patients without prior surgical experience will have higher kinesiophobia levels than those with prior surgical experience.

Read the detailed description

Postoperative early mobilization is one of the most important components of the post-surgical recovery process, playing a critical role in preventing complications such as deep vein thrombosis, pulmonary complications, and bowel dysfunction, and in shortening hospital stay and accelerating functional recovery. However, a substantial proportion of patients undergoing elective abdominal surgery avoid movement due to concerns about postoperative pain, the surgical incision, drains, and possible complications; this phenomenon is described in the literature as 'kinesiophobia' (fear of movement). Kinesiophobia is defined as an excessive, irrational fear of movement resulting from a feeling of vulnerability to painful injury or re-injury. In recent years, kinesiophobia has increasingly been studied in cardiac surgery and various other surgical patient groups, but studies examining the relationship between kinesiophobia and postoperative pain and early mobilization in elective abdominal surgery patients are limited.

This descriptive and cross-sectional study aims to determine the level of kinesiophobia in patients undergoing elective abdominal surgery and to examine its relationship with postoperative pain severity and early mobilization (time to first standing and first walking duration).

Research Questions:

  1. What are the kinesiophobia levels of patients undergoing elective abdominal surgery?
  2. What are the patients' postoperative pain severity and early mobilization (time to first standing, first walking duration) levels?
  3. Is there a relationship between patients' kinesiophobia levels and postoperative pain severity?
  4. Is there a relationship between patients' kinesiophobia levels and early mobilization levels?
  5. Do patients' sociodemographic and clinical characteristics (age, sex, body mass index, type of surgery, prior surgical experience) affect their kinesiophobia levels?

Hypotheses:

H1: There is a significant positive relationship between patients' kinesiophobia levels and postoperative pain severity.

H2: There is a significant positive relationship between patients' kinesiophobia levels and time to first standing (kinesiophobia level increases as mobilization is delayed).

H3: There is a significant relationship between patients' kinesiophobia levels and first walking duration/distance.

H4: Patients without prior surgical experience have significantly higher kinesiophobia levels than patients with prior surgical experience.

The study will be conducted at the General Surgery clinics of two centers, Agri Training and Research Hospital and Taksim Training and Research Hospital (multicenter). Data will be collected in a single cross-section, during the period when patients complete their first postoperative mobilization (typically postoperative day 1); no experimental intervention will be applied within the scope of the study.

The study population will consist of adult patients who undergo elective abdominal surgery in the General Surgery clinics of the two participating hospitals and complete their first postoperative mobilization on postoperative day 1. Inclusion criteria: age 18 years or older; having undergone elective (planned) abdominal surgery; having had surgery under general anesthesia; ASA (American Society of Anesthesiologists) physical status class I-II; having completed first mobilization on postoperative day 1; able to communicate in Turkish and understand written/verbal directions; conscious and oriented; willing to voluntarily participate and provide informed consent. Exclusion criteria: a known pre-existing walking/movement disorder, balance problem, or orthopedic-neurological disease history; having undergone emergency surgery; being followed in an intensive care unit; having a significant cognitive impairment or communication difficulty that prevents responding to data collection tools; having a visual or hearing impairment that prevents completing the forms/scales; being in a state of heavy postoperative sedation or delirium; having previously been enrolled in the same study; refusing to participate.

Sample size was calculated using G*Power 3.1 based on the bivariate correlation between two variables. Using a medium effect size (r=0.30) reported in similar studies examining the kinesiophobia-pain relationship, with alpha=0.05 and power (1-beta)=0.80, a minimum of 85 patients was calculated as necessary. Accounting for possible data loss, a total sample size of 120 patients (60 per center) is targeted.

Data will be collected using a data collection form and clinical observation record consisting of three sections: (1) a Patient Identification and Clinical Characteristics Form developed by the researchers based on the literature, recording age, sex, body mass index, education level, ASA physical status class, chronic disease history, prior surgical experience, type and duration of the surgical procedure, type of anesthesia, and time elapsed after surgery; (2) the Tampa Scale for Kinesiophobia (TSK), developed by Kori et al. and adapted into Turkish with validity and reliability testing by Tunca Yilmaz et al., a 17-item, 4-point Likert-type scale (1=strongly disagree to 4=strongly agree) with total scores ranging from 17-68, with higher scores indicating greater kinesiophobia (written permission for use of the scale items will be obtained from the Turkish adaptation authors prior to use); (3) the Numeric Rating Scale (NRS), scored from 0 (no pain) to 10 (worst imaginable pain), used to assess postoperative pain severity both at rest and during movement; and (4) an Early Mobilization Record Form developed by the researchers, recording the time of first standing after surgery, the duration the patient was able to remain standing at first mobilization, and the distance/duration of the first walk, based on nursing observation records and patient self-report. Completion of the data collection form and scale is expected to take approximately 10-15 minutes.

Study data will be collected by the researchers after obtaining ethics committee and institutional approvals. After patients meeting the inclusion criteria complete their first postoperative mobilization, the purpose of the study will be explained and written informed consent obtained. In a face-to-face interview with consenting patients, the Patient Identification and Clinical Characteristics Form and the Tampa Scale for Kinesiophobia will be completed, and postoperative pain severity will be queried with the NRS during the same interview. The time and duration of first mobilization will be recorded on the Early Mobilization Record Form based on nursing observation records together with patient self-report. Data collection will be carried out in an environment appropriate to each patient's clinical condition and ensuring privacy.

Data obtained from the study will be analyzed using IBM SPSS Statistics (Statistical Package for the Social Sciences). The distributional characteristics of the data will first be evaluated with the Shapiro-Wilk test. Descriptive statistics will use counts and percentages for categorical variables, and means, standard deviations, medians, and minimum-maximum values for continuous variables. The relationship between TSK total score and NRS pain score and mobilization durations will be evaluated with Pearson or Spearman correlation analysis depending on the distributional characteristics of the data. Two-group comparisons (e.g., patients with/without prior surgical experience) will use the independent samples t-test or Mann-Whitney U test depending on distribution; comparisons among more than two groups will use one-way ANOVA or the Kruskal-Wallis test. Multiple linear regression analysis will be applied to identify variables predicting kinesiophobia level. Statistical significance will be accepted at p<0.05; relationship magnitudes and 95% confidence intervals will be reported.

Anticipated difficulties include: patients' participation in data collection may be limited by postoperative pain, fatigue, or sedation; the timing of first mobilization may vary from patient to patient and according to clinical workload; mobilization information in nursing observation records may be incomplete or non-standardized; conducting the study at two different hospitals may make it difficult to standardize clinical practice for data collection; there is a possibility of social desirability bias given that kinesiophobia is assessed with a self-report scale; and if the planned sample size cannot be reached within the planned timeframe, the data collection period may need to be extended.

Limitations: due to the cross-sectional design of the study, the relationships among kinesiophobia, pain, and mobilization cannot be interpreted as cause-and-effect, but only at the level of association. Additionally, since the study will be conducted at only two hospitals and with patients who agree to participate, the generalizability of the findings to the broader elective abdominal surgery patient population is limited.

Conditions
Kinesiophobia
Being tested
Tampa Scale for Kinesiophobia (TSK)
Keywords
Fear of Movement, Postoperative Pain, Early Mobilization, Abdominal Surgery, Tampa Scale for Kinesiophobia
Medical subject headings
Kinesiophobia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tampa Scale for Kinesiophobia (TSK)Diagnostic test

    A single assessment battery administered after the patient completes first postoperative mobilization, consisting of the Turkish version of the 17-item Tampa Scale for Kinesiophobia (TSK) to measure fear of movement, the Numeric Rating Scale (NRS, 0-10) to assess postoperative pain at rest and during movement, and a researcher-developed Early Mobilization Record Form documenting time to first standing, standing duration, and first walking distance/duration. No experimental intervention or treatment is applied.

Study groups in NCT07834554
Study groupRoleWhat they receive
Elective Abdominal Surgery PatientsAdult patients who underwent elective abdominal surgery under general anesthesia at Agri Training and Research Hospital or Taksim Training and Research Hospital and completed their first postoperative mobilization (typically postoperative day 1). No experimental intervention is applied; participants complete the Patient Identification and Clinical Characteristics Form, the Tampa Scale for Kinesiophobia (TSK), and the Numeric Rating Scale (NRS) for pain, and their early mobilization (time to first standing, first walking duration/distance) is recorded via nursing observation and patient self-report.
Receives: Diagnostic Test: Tampa Scale for Kinesiophobia (TSK)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kinesiophobia Level (Tampa Scale for Kinesiophobia Score)

    Kinesiophobia (fear of movement) level assessed with the Turkish version of the 17-item Tampa Scale for Kinesiophobia (TSK), a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with total scores ranging from 17-68. Higher scores indicate greater kinesiophobia.

    Measured: Assessed once, at the time the patient completes first postoperative mobilization (typically postoperative day 1)

Secondary outcomes (3)
  1. Postoperative Pain Severity (Numeric Rating Scale)

    Postoperative pain severity assessed with the Numeric Rating Scale (NRS), scored from 0 (no pain) to 10 (worst imaginable pain), evaluated both at rest and during movement.

    Measured: Assessed once, at the time the patient completes first postoperative mobilization (typically postoperative day 1)

  2. Time to First Postoperative Standing

    Time elapsed from the end of surgery to the patient's first standing/ambulation attempt, recorded on the Early Mobilization Record Form from nursing observation records and patient self-report.

    Measured: Recorded once, at the time of first postoperative mobilization (typically postoperative day 1)

  3. First Walking Distance/Duration

    Distance walked and/or duration of the patient's first postoperative walk, recorded on the Early Mobilization Record Form from nursing observation records and patient self-report.

    Measured: Recorded once, at the time of first postoperative mobilization (typically postoperative day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07834554
Sponsor's protocol ID
AICU-KINEZYOFOBI-2026
Status last verified
Sep 2026
First submitted
16 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share individual participant data beyond what is reported in publications resulting from this study; per the study protocol, data will be used only for the purposes of this research and will not be shared with individuals outside the research team.

Publications

  • Schandl A, Siesage K, Kroksmark AK, Gruber-De Sousa E, Lilliecrona J, Olsen MF. Early mobilisation after abdominal surgery: a concept analysis. BMJ Open. 2026 Apr 17;16(4):e107830. doi: 10.1136/bmjopen-2025-107830.

    PubMed 41997707
  • Sharif-Nia H, Nazari R, Hajihosseini F, Froelicher ES, Osborne JW, Taebbi S, Nowrozi P. The relationship of fear of pain, pain anxiety, and fear-avoidance beliefs with perceived stress in surgical patients with postoperative kinesiophobia. BMC Psychol. 2025 Apr 22;13(1):420. doi: 10.1186/s40359-025-02743-8.

    PubMed 40264201
  • Gulsen M, Arslan S, Ceren E, Binokay H, Dogan OF. The effect of pain on fear of movement in the early period after open heart surgery according to the fear-avoidance model: the role of moderating factors. BMC Nurs. 2025 Nov 19;24(1):1413. doi: 10.1186/s12912-025-04059-9.

    PubMed 41257859
  • Tunca Yılmaz, Ö., Yakut, Y., Uygur, F., & Uluğ, N. (2011). Tampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği. Fizyoterapi Rehabilitasyon, 22(1), 44-49.

  • Kori, S. H., Miller, R. P., & Todd, D. D. (1990). Kinesiophobia: a new view of chronic pain behavior. Pain Management, 3, 35-43.

Questions about this trial

What is this clinical trial studying?

An observational study of Kinesiophobia, run by Volkan Gokmen at 2 sites 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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Volkan Gokmen, PhD (+90 532 739 0938, vgokmen@agri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinesiophobia Level (Tampa Scale for Kinesiophobia Score) (time frame: Assessed once, at the time the patient completes first postoperative mobilization (typically postoperative day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07834554, which also lists 5 linked publications.

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 24 Sep 2026.

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