Nursing CareNCT06529471
Effect of Massage After CABG on Pain, Sleep Quality and Serum Cortisol Level
A study testing Massage group in people with Nursing Care and Massage, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The patient in the surgical treatment and care process has difficulty in meeting the need for sleep in the hospital, and accordingly, their habits, attitudes and behaviors regarding sleep and rest change. Read more about this study
- Who is it for?
- Ages 40 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Care, Massage, Pain
- What is being tested?
- Massage group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 24 Jul 2024
- 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 40 to 71 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planning for elective open heart surgery
- Being conscious
- Being extubated
Who cannot join
- Those who underwent minimally invasive cardiac surgery,
- Those who did not use an extracorporeal circulation machine
- Those who have an infectious disease such as varicella zoster on the back, or a structural disease such as scoliosis,
- Those who have another surgical procedure performed simultaneously on the back,
- Those who have no limb loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Massage Applied After Open Cardiovascular Surgery on Patients' Pain, Sleep Quality and Serum Cortisol Level
The patient in the surgical treatment and care process has difficulty in meeting the need for sleep in the hospital, and accordingly, their habits, attitudes and behaviors regarding sleep and rest change. Studies have shown that hospitalized patients experience sleep deprivatio.The decrease in sleep duration and quality is an important component affecting recovery after surgery. Studies have reported that massage reduces physical and emotional stress and increases sleep quality, while back massage reduces pain, anxiety and sleep disorders.
It has been reported that back massage reduces cortisol levels and blood pressure, slows heart rate and improves sleep quality (Pınar and Afşar 2015). This study was planned as a case-control study to evaluate the effect of massage therapy applied after open cardiovascular surgery on patients' pain, sleep quality and serum cortisol levels. It is thought that the study will create literature information on the sleep quality, pain and serum cortisol levels of patients after open heart surgery.
Read the detailed description
Surgery is seen as an unexpected and negative experience in the lives of patients and their relatives. During the surgical procedure, the differences in the environment and lifestyle of patients, pain, changes in the body, the possibility of individual respect or disruption of body integrity may cause them to experience anxiety and fear. Patients in the treatment and care process have difficulty meeting their sleep needs in the hospital, and their habits, attitudes and behaviors regarding sleep and rest change accordingly.Studies have shown that hospitalized patients experience sleep deprivation. Different definitions of sleep have been made; however, according to the most common definition, sleep is a state of unconsciousness during the resting of the brain and from which the person can be awakened by external stimuli. Sleep, which has an important place in physical and mental health, has different aspects such as total duration, latency, regularity and quality. Sleep quality includes the quantitative (sleep latency, sleep duration, and number of awakenings per night) and qualitative (depth and restfulness of sleep) aspects of sleep. An average of 7-8 hours of sleep is needed daily and varies according to individual characteristics such as age, gender, nutrition, activity, health status, and physical environment, and accordingly, sleep quality can be affected both quantitatively and qualitatively. In the literature, it is reported that the sleep processes of hospitalized patients are negatively affected; this symptom is seen in 48-90% of patients in the postoperative period; and the cause of sleep problems is often pain. Surgical interventions affect the physiological and psychological health of patients and cause patients to experience great anxiety and fear about their lives and future. In addition, it is reported that general anesthetic drugs disrupt the sleep/wake cycle and other circadian rhythms such as body temperature and melatonin secretion. It is stated that sleep quality is low due to reasons such as postoperative pain, anxiety about the disease and positional restrictions after the intervention. Short and poor sleep duration reduces uninterrupted sleep and disrupts the 24-hour circadian rhythm and normal sleep pattern. In this sense, poor sleep quality can cause multi-system effects such as increased proinflammatory cytokines, blood pressure changes, increased risk of heart attack, hormonal stress response, glucose intolerance and suppression of the immune system. Therefore, the need for adequate sleep should be taken into account in both preoperative and postoperative care of surgical patients. Decreased sleep duration and quality is an important component affecting postoperative recovery. Because when combined with surgical stress, it can lead to increased catabolic activity and tissue destruction as well as decreased anabolic activity, which in turn affects postoperative recovery. Indeed, animal models have shown that sleep deprivation leads to depletion of glycogen stores and increases oxidative stress and free radical production, as well as the production of proinflammatory cytokines, all of which contribute to poor postoperative recovery. In a study conducted with patients in intensive care, it was reported that on average half of the patients had sleep problems and these problems continued after discharge, and that sleep problems in these clinics were pain, ventilation modes, and medications. In the study conducted by Sivas et al., it was stated that there was a significant relationship between pain, sleep disturbance, and quality of life. It was also determined that postoperative sleep quality was poor in patients who underwent cardiothoracic surgery and this situation lasted for more than 6 months. It is stated that patients in surgical clinics have low sleep quality due to reasons such as pain, anxiety related to the disease, encountering unknowns after surgery, and positional restrictions. Determining and eliminating the factors affecting the patient's sleep needs, ensuring and maintaining a normal sleep process are among the independent nursing roles. The stress response shows its effects by affecting vital organs and systems such as the central nervous, circulatory, gastrointestinal and immune systems, mainly through the autonomic nervous system and the hypothalamic-pituitary-adrenal (HPA) axis. Stress and the stress response can cause various clinically negative health outcomes (coronary artery disease, arrhythmia, memory problems, etc.). Numerous strategies have been developed and studied to alleviate the potential negative health effects of stress through effective management of stress with cognitive perceptual methods such as meditation, mindfulness and massage In addition to medical practices, nurses also use complementary practices to overcome symptoms such as insomnia, fatigue and pain. One of these practices, massage, is a simple, applicable, non-invasive method used to provide relaxation. The palpation of soft tissues and muscles provides both physical and mental relaxation for the person. In addition, massage is a therapeutic method that provides energy transmission between the nurse and the patient. Studies have reported that massage reduces physical and emotional stress and increases sleep quality, while back massage reduces pain, anxiety and sleep disorders. It has been reported that back massage reduces cortisol levels and blood pressure, slows down heart rate and increases sleep quality. This study was planned as a case-control study to evaluate the effect of massage applied after open heart surgery on pain, sleep quality and serum cortisol levels of patients. It is thought that the study will create literature information on the sleep quality, pain and serum cortisol levels of patients applied after open heart surgery.
- Conditions
- Nursing Care, Massage, Pain, Cortisol
- Being tested
- Massage group
- Keywords
- massage, pain, nursing care, sleep, cortisol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage groupOther
The patient in the massage group will be visited by the practitioner 3 times at 10:00-14:00-20:00 on the first day after surgery and a back massage will be applied. The patient in the massage group will be placed in an orthopnea position during the application. The massage procedure lasts an average of 30 minutes and is applied to the cervical 3 and thoracic 12 vertebrae.
| Study group | Role | What they receive |
|---|---|---|
| Group receiving massage | Experimental | In Postoperative 0, before the massage, the patient's sleep duration (with the Richard-Campbell Sleep Scale and smart watch) and cortisol level are measured (first test). In Postoperative 1, a back massage is applied three times (10:00-14:00-20:00). In Postoperative 2, sleep duration (with the Richard-Campbell Sleep Scale and smart watch) and cortisol level are measured (last test). Receives: Other: Massage group |
| Standard care group | No intervention | The patients in this group are given routine care practices of the clinic. Sleep and cortisol measurements are made in parallel with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Richard-Campbell Sleep Scale: RCSQ is a 6-item scale that evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time it takes to stay awake when you wake up, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart from 0 to 100 using the visual analog scale technique. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. As the score of the scale increases, the sleep quality of the patients also increases.
Measured: Before the recruit pre-test (RCSQ- survey scale) will be applied. A post-test (RCSQ survey scale) will be administered again two days after the intervention.]
Postoperative Pain Intensity (Numeric Rating Scale)
Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates "no pain" and 10 indicates "worst possible pain." Pain will be measured at standardized time points for all participants. In the intervention group, pain will be assessed immediately before each massage session and 10 minutes after each session. In the control group, pain assessments will follow the same schedule corresponding to routine care time points. Higher scores indicate greater pain severity.
Measured: Measured before each session and 10 minutes after each session, as well as on postoperative days 1 and 2.
Secondary outcomes (1)
Secondary Outcome Measure
Serum Cortisol Level Analysis: Blood samples will be placed in tubes containing separator gel (SST-yellow tube) and serum cortisol levels will be analyzed in the relevant laboratory.
Measured: Before the recruit pre-test (serum cortisol-blood test) will be applied. A post-test (serum cortisol-blood test) will be administered two days after the intervention.]
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 2023
- Primary completion4 Sep 2023
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CareStudies 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
- The study was conducted experimentally with a pre-test and post-test control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN ÖZHANLI, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529471
- Sponsor's protocol ID
- 2023/11.26
- Other IDs
- Kocaeli University
- Status last verified
- Nov 2025
- First submitted
- 26 Jul 2024
- Last updated
- 24 Nov 2025
- Results posted
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage Applied After Open Cardiovascular Surgery on Patients' Pain, Sleep Quality and Serum Cortisol Level
- ClinicalTrials.gov ID
- NCT06529471
- Acronym / sponsor ID
- 2023/11.26
- Conditions
- Nursing Care, Massage, Pain, Cortisol
- Keywords
- massage, pain, nursing care, sleep, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 24 Jul 2024 (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.
The patient in the surgical treatment and care process has difficulty in meeting the need for sleep in the hospital, and accordingly, their habits, attitudes and behaviors regarding sleep and rest change. Studies have shown that hospitalized patients experience sleep deprivatio.The decrease in sleep duration and quality is an important component affecting recovery after surgery. Studies have reported that massage reduces physical and emotional stress and increases sleep quality, while back massage reduces pain, anxiety and sleep disorders.
It has been reported that back massage reduces cortisol levels and blood pressure, slows heart rate and improves sleep quality (Pınar and Afşar 2015). This study was planned as a case-control study to evaluate the effect of massage therapy applied after open cardiovascular surgery on patients' pain, sleep quality and serum cortisol levels. It is thought that the study will create literature information on the sleep quality, pain and serum cortisol levels of patients after open heart surgery.
Detailed description
Surgery is seen as an unexpected and negative experience in the lives of patients and their relatives. During the surgical procedure, the differences in the environment and lifestyle of patients, pain, changes in the body, the possibility of individual respect or disruption of body integrity may cause them to experience anxiety and fear. Patients in the treatment and care process have difficulty meeting their sleep needs in the hospital, and their habits, attitudes and behaviors regarding sleep and rest change accordingly.Studies have shown that hospitalized patients experience sleep deprivation. Different definitions of sleep have been made; however, according to the most common definition, sleep is a state of unconsciousness during the resting of the brain and from which the person can be awakened by external stimuli. Sleep, which has an important place in physical and mental health, has different aspects such as total duration, latency, regularity and quality. Sleep quality includes the quantitative (sleep latency, sleep duration, and number of awakenings per night) and qualitative (depth and restfulness of sleep) aspects of sleep. An average of 7-8 hours of sleep is needed daily and varies according to individual characteristics such as age, gender, nutrition, activity, health status, and physical environment, and accordingly, sleep quality can be affected both quantitatively and qualitatively. In the literature, it is reported that the sleep processes of hospitalized patients are negatively affected; this symptom is seen in 48-90% of patients in the postoperative period; and the cause of sleep problems is often pain. Surgical interventions affect the physiological and psychological health of patients and cause patients to experience great anxiety and fear about their lives and future. In addition, it is reported that general anesthetic drugs disrupt the sleep/wake cycle and other circadian rhythms such as body temperature and melatonin secretion. It is stated that sleep quality is low due to reasons such as postoperative pain, anxiety about the disease and positional restrictions after the intervention. Short and poor sleep duration reduces uninterrupted sleep and disrupts the 24-hour circadian rhythm and normal sleep pattern. In this sense, poor sleep quality can cause multi-system effects such as increased proinflammatory cytokines, blood pressure changes, increased risk of heart attack, hormonal stress response, glucose intolerance and suppression of the immune system. Therefore, the need for adequate sleep should be taken into account in both preoperative and postoperative care of surgical patients. Decreased sleep duration and quality is an important component affecting postoperative recovery. Because when combined with surgical stress, it can lead to increased catabolic activity and tissue destruction as well as decreased anabolic activity, which in turn affects postoperative recovery. Indeed, animal models have shown that sleep deprivation leads to depletion of glycogen stores and increases oxidative stress and free radical production, as well as the production of proinflammatory cytokines, all of which contribute to poor postoperative recovery. In a study conducted with patients in intensive care, it was reported that on average half of the patients had sleep problems and these problems continued after discharge, and that sleep problems in these clinics were pain, ventilation modes, and medications. In the study conducted by Sivas et al., it was stated that there was a significant relationship between pain, sleep disturbance, and quality of life. It was also determined that postoperative sleep quality was poor in patients who underwent cardiothoracic surgery and this situation lasted for more than 6 months. It is stated that patients in surgical clinics have low sleep quality due to reasons such as pain, anxiety related to the disease, encountering unknowns after surgery, and positional restrictions. Determining and eliminating the factors affecting the patient's sleep needs, ensuring and maintaining a normal sleep process are among the independent nursing roles. The stress response shows its effects by affecting vital organs and systems such as the central nervous, circulatory, gastrointestinal and immune systems, mainly through the autonomic nervous system and the hypothalamic-pituitary-adrenal (HPA) axis. Stress and the stress response can cause various clinically negative health outcomes (coronary artery disease, arrhythmia, memory problems, etc.). Numerous strategies have been developed and studied to alleviate the potential negative health effects of stress through effective management of stress with cognitive perceptual methods such as meditation, mindfulness and massage In addition to medical practices, nurses also use complementary practices to overcome symptoms such as insomnia, fatigue and pain. One of these practices, massage, is a simple, applicable, non-invasive method used to provide relaxation. The palpation of soft tissues and muscles provides both physical and mental relaxation for the person. In addition, massage is a therapeutic method that provides energy transmission between the nurse and the patient. Studies have reported that massage reduces physical and emotional stress and increases sleep quality, while back massage reduces pain, anxiety and sleep disorders. It has been reported that back massage reduces cortisol levels and blood pressure, slows down heart rate and increases sleep quality. This study was planned as a case-control study to evaluate the effect of massage applied after open heart surgery on pain, sleep quality and serum cortisol levels of patients. It is thought that the study will create literature information on the sleep quality, pain and serum cortisol levels of patients applied after open heart surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was conducted experimentally with a pre-test and post-test control group.
| Arm | Type | Receives |
|---|---|---|
| Group receiving massage | Experimental | Other: Massage groupIn Postoperative 0, before the massage, the patient's sleep duration (with the Richard-Campbell Sleep Scale and smart watch) and cortisol level are measured (first test). In Postoperative 1, a back massage is applied three times (10:00-14:00-20:00). In Postoperative 2, sleep duration (with the Richard-Campbell Sleep Scale and smart watch) and cortisol level are measured (last test). |
| Standard care group | No intervention | –The patients in this group are given routine care practices of the clinic. Sleep and cortisol measurements are made in parallel with the experimental group. |
Who may qualify
- Ages
- 40 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planning for elective open heart surgery
- Being conscious
- Being extubated
Key exclusion criteria (5 listed)
- Those who underwent minimally invasive cardiac surgery,
- Those who did not use an extracorporeal circulation machine
- Those who have an infectious disease such as varicella zoster on the back, or a structural disease such as scoliosis,
- Those who have another surgical procedure performed simultaneously on the back,
- Those who have no limb loss
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 |
|---|---|---|
| Massage groupThe patient in the massage group will be visited by the practitioner 3 times at 10:00-14:00-20:00 on the first day after surgery and a back massage will be applied. The patient in the massage group will be placed in an orthopnea position during the application. The massage procedure lasts an average of 30 minutes and is applied to the cervical 3 and thoracic 12 vertebrae. | Other | Group receiving massage |
Primary outcome
Primary Outcome Measure
Time frame: Before the recruit pre-test (RCSQ- survey scale) will be applied. A post-test (RCSQ survey scale) will be administered again two days after the intervention.]
Richard-Campbell Sleep Scale: RCSQ is a 6-item scale that evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time it takes to stay awake when you wake up, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart from 0 to 100 using the visual analog scale technique. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. As the score of the scale increases, the sleep quality of the patients also increases.
Postoperative Pain Intensity (Numeric Rating Scale)
Time frame: Measured before each session and 10 minutes after each session, as well as on postoperative days 1 and 2.
Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates "no pain" and 10 indicates "worst possible pain." Pain will be measured at standardized time points for all participants. In the intervention group, pain will be assessed immediately before each massage session and 10 minutes after each session. In the control group, pain assessments will follow the same schedule corresponding to routine care time points. Higher scores indicate greater pain severity.
1 secondary outcome
Secondary Outcome Measure
Time frame: Before the recruit pre-test (serum cortisol-blood test) will be applied. A post-test (serum cortisol-blood test) will be administered two days after the intervention.]
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 24 Nov 2025.
- 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 group in people with Nursing Care and Massage, run by Kocaeli 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 3 inclusion and 5 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 24 Nov 2025. 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?
Primary Outcome Measure (time frame: Before the recruit pre-test (RCSQ- survey scale) will be applied. A post-test (RCSQ survey scale) will be administered again two days after the intervention.]). The study lists 2 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 24 Nov 2025.