Pain, PostoperativeNCT05567107
The Effect of Foot Massage After Open Heart Surgery on Postoperative Pain, Sleep Quality and Mood of Patients
A study testing massage in people with Pain, Postoperative and Sleep Disturbance, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The randomized controlled experimental study was conducted in the cardiovascular surgery clinic of Atatürk University Health Practice and Research Center between April 2021 and September 2021.The research sample consisted of 91 patients who met the research criteria. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Sleep Disturbance, Mood
- What is being tested?
- massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2021to 14 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The randomized controlled experimental study was conducted in the cardiovascular surgery clinic of Atatürk University Health Practice and Research Center between April 2021 and September 2021.The research sample consisted of 91 patients who met the research criteria. Since exclusion criteria were met in 15 patients during the research process, the study was completed with 76 patients. Descriptive Information Form, Visual Analog Scale, State-Trait Anxiety Scale, Visual Analog Sleep Scale and Hospital Anxiety and Depression Scale were used as data collection tools. All scales were applied to the patients preoperatively. According to the Postoperative Visual Analog Scale, the patients in the experimental group who stated that they had more than 4 pains were given foot massage for a total of 20 minutes, 10 minutes on each foot. After the surgery, classical foot massage was applied to the patients for 3 consecutive days, including the day they came to the service from the intensive care unit. One day after each application, the patients' pain, sleep quality and mood levels were examined. Data were collected by applying the same procedure steps without foot massage to the patients in the control group.
Read the detailed description
Pain still remains a major problem in patients undergoing coronary artery bypass graft surgery. Pain and anxiety are conditions that should be evaluated together and affect each other. Anxiety has a significant effect on the reduction or increase in post-operative pain. Pain experienced after surgery increases the anxiety of the individual. Increasing anxiety level negatively affects sleep quality. The inability to manage the pain experienced in the early postoperative period and the associated anxiety negatively affect the healing process, increasing the risk of complications that may occur after the surgery, which negatively affects the quality of life. It also increases mortality and morbidity rates. Pain management is very important because of the negative effects seen due to pain. It is seen that there are many pharmacological and non-pharmacological methods used to prevent pain and anxiety experienced after surgical intervention. One of these methods is massage, which is known for its therapeutic and healing effects and has a positive effect on the body. It is predicted that with the foot massage applied after coronary artery bypass graft surgery, the postoperative pain and anxiety level of the patients will decrease, it will have a positive effect on their mood and their sleep quality will increase. In addition, it is thought that with the increase of studies on the application of foot massage in patients who have undergone coronary artery bypass graft surgery, a non-pharmacological routine application can be created on patients in surgical services and the level of satisfaction in nursing can be increased.
- Conditions
- Pain, Postoperative, Sleep Disturbance, Mood, Bypass Complication
- Being tested
- massage
- Keywords
- sleep quality, open heart surgery, foot massage, pain, mood
- Medical subject headings
- Pain, Postoperative, Parasomnias, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
Classical foot massage was applied by the researcher with effleurage, superficial friction and petrissage techniques for 10 minutes on each foot.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Foot massage + routine postoperative care | Experimental | 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. Receives: Other: massage |
| No Intervention: Routine postoperative care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
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"
Measured: [Time Frame: up to 24 hours]
State-Trait Anxiety İnventory (STAI-I, STAI-II)
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).
Measured: [Time Frame: up to 24 hours]
Visual Comparison Sleep Scale
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.
Measured: [Time Frame: up to 24 hours]
Hospital Anxiety and Depression Scale
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.
Measured: [Time Frame: up to 24 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start10 Apr 2021
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyzanur Kızıloğlu Ağgül, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567107
- Sponsor's protocol ID
- BKiziloglu
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2022
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Massage After Open Heart Surgery on Postoperative Pain, Sleep Quality and Mood of Patients
- ClinicalTrials.gov ID
- NCT05567107
- Acronym / sponsor ID
- BKiziloglu
- Conditions
- Pain, Postoperative, Sleep Disturbance, Mood, Bypass Complication
- Keywords
- sleep quality, open heart surgery, foot massage, pain, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 5 Oct 2022 (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.
The randomized controlled experimental study was conducted in the cardiovascular surgery clinic of Atatürk University Health Practice and Research Center between April 2021 and September 2021.The research sample consisted of 91 patients who met the research criteria. Since exclusion criteria were met in 15 patients during the research process, the study was completed with 76 patients. Descriptive Information Form, Visual Analog Scale, State-Trait Anxiety Scale, Visual Analog Sleep Scale and Hospital Anxiety and Depression Scale were used as data collection tools. All scales were applied to the patients preoperatively. According to the Postoperative Visual Analog Scale, the patients in the experimental group who stated that they had more than 4 pains were given foot massage for a total of 20 minutes, 10 minutes on each foot. After the surgery, classical foot massage was applied to the patients for 3 consecutive days, including the day they came to the service from the intensive care unit. One day after each application, the patients' pain, sleep quality and mood levels were examined. Data were collected by applying the same procedure steps without foot massage to the patients in the control group.
Detailed description
Pain still remains a major problem in patients undergoing coronary artery bypass graft surgery. Pain and anxiety are conditions that should be evaluated together and affect each other. Anxiety has a significant effect on the reduction or increase in post-operative pain. Pain experienced after surgery increases the anxiety of the individual. Increasing anxiety level negatively affects sleep quality. The inability to manage the pain experienced in the early postoperative period and the associated anxiety negatively affect the healing process, increasing the risk of complications that may occur after the surgery, which negatively affects the quality of life. It also increases mortality and morbidity rates. Pain management is very important because of the negative effects seen due to pain. It is seen that there are many pharmacological and non-pharmacological methods used to prevent pain and anxiety experienced after surgical intervention. One of these methods is massage, which is known for its therapeutic and healing effects and has a positive effect on the body. It is predicted that with the foot massage applied after coronary artery bypass graft surgery, the postoperative pain and anxiety level of the patients will decrease, it will have a positive effect on their mood and their sleep quality will increase. In addition, it is thought that with the increase of studies on the application of foot massage in patients who have undergone coronary artery bypass graft surgery, a non-pharmacological routine application can be created on patients in surgical services and the level of satisfaction in nursing can be increased.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Foot massage + routine postoperative care | Experimental | Other: massageParticipants 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. |
| No Intervention: Routine postoperative care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| massageClassical foot massage was applied by the researcher with effleurage, superficial friction and petrissage techniques for 10 minutes on each foot. | Other | Experimental: Foot massage + routine postoperative care |
Primary outcome
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"
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).
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.
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.
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 21 Aug 2026.
- 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 massage in people with Pain, Postoperative and Sleep Disturbance, run by Ataturk 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 1 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 21 Aug 2026. 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?
Visual analog scale (time frame: [Time Frame: up to 24 hours]). The study lists 4 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 21 Aug 2026.