- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05567107
The Effect of Foot Massage After Open Heart Surgery on Postoperative Pain, Sleep Quality and Mood of Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
palandöken
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Erzurum, palandöken, Turkey (Türkiye), 25000
- Beyzanur Kızıloğlu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged 18 years or older Scheduled to undergo elective coronary artery bypass grafting (CABG) surgery Voluntarily agreed to participate and provided informed consent Able to communicate verbally and understand the study procedures Hemodynamically stable following transfer from the intensive care unit to the cardiovascular surgery ward Reported a postoperative pain intensity of ≥4 on the Visual Analog Scale (VAS) Had no condition preventing the safe application of foot massage, including foot skin infection, local infection, open wound or lesion, significant edema or hematoma, thrombophlebitis, deep vein thrombosis, coagulation disorder, severe varicose veins, osteomyelitis, peripheral neuropathy, recent fracture, dislocation, or major musculoskeletal injury involving the lower extremities
Exclusion Criteria:
Development of a postoperative complication that prevented continuation of the intervention or study assessments Withdrawal of consent during the study Inability to complete the planned intervention or follow-up assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Foot massage + routine postoperative care
Participants allocated to the intervention group received classical foot massage in addition to routine postoperative care.
Baseline measurements were obtained preoperatively.
Following transfer from the intensive care unit to the ward, outcome measurements were performed on days 1, 2, 3, and 4. Classical foot massage was administered after the outcome measurements on days 1, 2, and 3.
Each massage session lasted 20 minutes, with 10 minutes applied to each foot.
|
Classical foot massage was applied by the researcher with effleurage, superficial friction and petrissage techniques for 10 minutes on each foot.
|
|
No Intervention: No Intervention: Routine postoperative care
Participants allocated to the control group received routine postoperative care only and did not receive foot massage.
Baseline measurements were obtained preoperatively, and outcome measurements were performed on days 1, 2, 3, and 4 following transfer from the intensive care unit to the ward, according to the same assessment schedule as the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale
Time Frame: [Time Frame: up to 24 hours]
|
The visual analog scale was used to evaluate the pain severity of the patient.
It is a self-reported scale in the form of a 10-cm ruler indicating no pain at one end and unbearable pain at the other.
Accordingly, the patient is told to evaluate his/her pain between 0 and 10, with 0 cm indicating "no pain" and 10 cm indicating "unbearable pain"
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[Time Frame: up to 24 hours]
|
|
State-Trait Anxiety İnventory (STAI-I, STAI-II)
Time Frame: [Time Frame: up to 24 hours]
|
It is a test developed by Spielberger et al. that measures state and trait anxiety levels.
Its validity and reliability in Turkey was done by O#ner and Le Compte.
The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general.
It is a four degree scale ranging from 'Nothing' to 'All'.
Scores range from 20 (low anxiety) to 80 (high anxiety).
|
[Time Frame: up to 24 hours]
|
|
Visual Comparison Sleep Scale
Time Frame: [Time Frame: up to 24 hours]
|
Scoring in this scale, whose Turkish version consists of 10 items, was formed by reversing the 2nd, 4th, 8th and 9th statements.
Each item in the scale was evaluated by visual comparison technique by showing it on the chart between 0 (on the left end) and 100 (on the right end).
The score obtained from the scale is between 0-1000.
An increase in the score obtained from the scale indicates a decrease in sleep quality.
|
[Time Frame: up to 24 hours]
|
|
Hospital Anxiety and Depression Scale
Time Frame: [Time Frame: up to 24 hours]
|
It consists of two subscales, depression and anxiety.
Each subscale includes 7 items.
There are 14 items in total.
While summing the scores of items 1, 3, 5, 7, 9, 11 and 13 for the Anxiety Subscale of the Hospital Anxiety and Depression Scale; For the Depression Sub-Scale, the scores of items 2, 4, 6, 8, 10, 12 and 14 are added.
Items 3, 5, 6, 8, 10, 11, and 13 of the Anxiety Sub-Scale of the Hospital Anxiety and Depression Scale show gradually decreasing severity and are scored in a 4-point Likert scale as 3, 2, 1, 0. Items 2, 4, 7, 9, 12 and 14 of the Depression Subscale of the Hospital Anxiety and Depression Scale show increasing severity and are scored as 0, 1, 2, 3 on a 4-point Likert scale.
The lowest score that patients can get from the Anxiety and Depression Subscales is 0, and the highest score is 21.
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[Time Frame: up to 24 hours]
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Pain, Postoperative
- Parasomnias
- Sleep Initiation and Maintenance Disorders
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
Other Study ID Numbers
- BKiziloglu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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