Postoperative PainNCT05617937
Effects of Connective Tissue Massage on Pain After Thoracotomy
A study testing Massage in people with Postoperative Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Pain can be quite severe after thoracic surgery and effective pain control is highly effective in preventing secretion accumulation, atelectasis, infection and hypoxemia. The objective was evaluate the effect of a connective tissue massage on pain, applied analgesic amounts and length of hospitalization of the… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2021to 1 Nov 2022
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Applying to Thoracic Surgery Department of Akdeniz University Hospital and undergoing thoracotomy via posterolateral thoracotomy incision,
- Being in age range of 20-75 years,
- Being stable in terms of hemodynamics,
- Having no metastatic dissemination,
- Having no known cerebrovascular disease,
- Having no morbid obesity and heart disease that may inhibit the study,
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- Having no cognitive impairment that may inhibit communication,
- Having no previous stroke and the associated influence,
- Having no inconvenience for connective tissue massage as a result of the evaluation made by the physician,
- Agreeing to participate in the study.
Who cannot join
- Having cardiovascular diseases,
- Having stage 3 (severe) or stage 4 (very severe) chronic obstructive pulmonary disease (COPD),
- Having more than 200 cc bleeding per hour from the drainage tubes,
- Having an intubation period longer than 24 hours,
- Interventions having a negative effect on the pain such as decortication, diaphragm eventration, thoracic wall resection that are performed by thoracotomy were excluded from in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effects of Connective Tissue Massage on Pain After Thoracotomy - Randomized Controlled Trial
Pain can be quite severe after thoracic surgery and effective pain control is highly effective in preventing secretion accumulation, atelectasis, infection and hypoxemia. The objective was evaluate the effect of a connective tissue massage on pain, applied analgesic amounts and length of hospitalization of the patients.The study was conducted at a thoracic surgery department of university hospital in Turkey. Fifty-four patients with operated by the posterolateral thoracotomy method participated.The patients were randomly allocated to 1 of 2 groups: a control group (n27) and the experimental group (n27). Standard medical treatment, care and pulmonary rehabilitation program were applied to both groups. In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group. Pain level of the patients was evaluated at every 24 hours as of the zeroth postoperative day. VAS was used as a one-dimensional scale for pain assessment. Totally applied analgesic amounts and length of hospitalization of the patients were recorded.
Read the detailed description
The patients were randomly divided into two groups as the control group and the experimental group by using the Microsoft Excel program (Microsoft Inc., Redmond, WA, USA). The population of the study consisted of the patients who were hospitalized at Thoracic Surgery Clinic and operated by the posterolateral thoracotomy method. The first group of the study consisted of the patients in the control group and the second group consisted of the connective tissue massage group. Lobectomy, pneumonectomy, segmentectomy or wedge resection surgeries were performed together with posterolateral thoracotomy in both patient groups.
Standard medical treatment, care and pulmonary rehabilitation program were applied to both groups. The patients were mobilized as early as possible. Starting on the postoperative zeroth day, a postoperative rehabilitation program including pulmonary rehabilitation and early mobilization was applied to every patient in the control and experimental groups by a therapist for 1 week as in routine.
In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Connective tissue massage was only performed to the patients in the experimental group. The procedure was performed while the patient was in the sitting position on a chair. In order to provide relaxation in the connective tissue, the patient was asked to perform a slight anterior tilt and to hold his back upright. The middle fingers were used bilaterally in order to provide traction between the cutaneous tissues. In order to prevent contraindication, the procedure was applied to the tissues that were 2 inch away from the surgical site. Throughout the procedure, oxygen saturation of the patient, if required, the heart rate and blood pressure were followed up. The connective tissue massage was started from the lumbosacral region (baseline) and was applied to the lower thoracic, scapular, inter-scapular and cervico-occipital region according to the vascular response of the connective tissue. A total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Depending on the area of procedure, each session varied between 15 minutes and 20 minutes. On postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day (before the massage in the experimental group) (between 8.00 and 9.00 in the morning); in other words, pain level of the patients (n=54) was evaluated at every 24 hours as of the zeroth postoperative day.
Totally applied analgesic amounts of the patients were recorded on the postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day. In addition, length of hospitalization of the patients was recorded.In the present study, it was found that the patients with prolonged hospitalization period had higher postoperative pain and the duration of hospitalization was longer in the control group. It was thought that this difference was caused by the effects of connective tissue massage on pain.
- Conditions
- Postoperative Pain
- Being tested
- Massage
- Keywords
- Connective tissue massage, Thoracotomy, Pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
The connective tissue massage was started from the lumbosacral region (baseline) and was applied to the lower thoracic, scapular, inter-scapular and cervico-occipital region according to the vascular response of the connective tissue.
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue massage gruop | Experimental | In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Connective tissue massage was only performed to the patients in the experimental group. A total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Depending on the area of procedure, each session varied between 15 minutes and 20 minutes. Receives: Other: Massage |
| Conventional Physiotherapy and Rehabilitation Group | No intervention | Standard medical treatment, care and pulmonary rehabilitation program were applied to bonventional Physiotherapy and Rehabilitation Group.The patients were mobilized as early as possible. Starting on the postoperative zeroth day, a postoperative rehabilitation program including pulmonary rehabilitation and early mobilization was applied to every patient in the control and experimental groups by a therapist for 1 week as in routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Score
On postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day (before the massage in the experimental group) (between 8.00 and 9.00 in the morning); in other words, pain level of the patients (n=54) was evaluated at every 24 hours as of the zeroth postoperative day.
Measured: Change from Baseline Pain Score at 7 days.
Change of applied analgesic amounts of the patients
Totally applied analgesic amounts of the patients were recorded on the postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day. In addition, length of hospitalization of the patients was recorded.
Measured: Change from Baseline applied analgesic amounts of the patients at 7 days.
Secondary outcomes (3)
Height in Meters
The height of all subjects in meters (m) will be noted before the surgery.
Measured: Initial assessment before surgery.
Weight in Kilograms
The weight of all subjects in kilograms (kg) will be noted before the surgery.
Measured: Initial assessment before surgery.
Body Mass Index (BMI) in kg/m^2
Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.
Measured: Initial assessment before surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start23 Apr 2021
- Primary completion22 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neriman Temel Aksu, Akdeniz University
- Investigators
- Neriman Aksu, Principal investigator, Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617937
- Sponsor's protocol ID
- AkdenizUniversitythoracic
- Status last verified
- Nov 2022
- First submitted
- 23 Mar 2021
- Last updated
- 16 Nov 2022
- 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 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Connective Tissue Massage on Pain After Thoracotomy - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05617937
- Acronym / sponsor ID
- AkdenizUniversitythoracic
- Conditions
- Postoperative Pain
- Keywords
- Connective tissue massage, Thoracotomy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 16 Nov 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.
Pain can be quite severe after thoracic surgery and effective pain control is highly effective in preventing secretion accumulation, atelectasis, infection and hypoxemia. The objective was evaluate the effect of a connective tissue massage on pain, applied analgesic amounts and length of hospitalization of the patients.The study was conducted at a thoracic surgery department of university hospital in Turkey. Fifty-four patients with operated by the posterolateral thoracotomy method participated.The patients were randomly allocated to 1 of 2 groups: a control group (n27) and the experimental group (n27). Standard medical treatment, care and pulmonary rehabilitation program were applied to both groups. In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group. Pain level of the patients was evaluated at every 24 hours as of the zeroth postoperative day. VAS was used as a one-dimensional scale for pain assessment. Totally applied analgesic amounts and length of hospitalization of the patients were recorded.
Detailed description
The patients were randomly divided into two groups as the control group and the experimental group by using the Microsoft Excel program (Microsoft Inc., Redmond, WA, USA). The population of the study consisted of the patients who were hospitalized at Thoracic Surgery Clinic and operated by the posterolateral thoracotomy method. The first group of the study consisted of the patients in the control group and the second group consisted of the connective tissue massage group. Lobectomy, pneumonectomy, segmentectomy or wedge resection surgeries were performed together with posterolateral thoracotomy in both patient groups.
Standard medical treatment, care and pulmonary rehabilitation program were applied to both groups. The patients were mobilized as early as possible. Starting on the postoperative zeroth day, a postoperative rehabilitation program including pulmonary rehabilitation and early mobilization was applied to every patient in the control and experimental groups by a therapist for 1 week as in routine.
In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Connective tissue massage was only performed to the patients in the experimental group. The procedure was performed while the patient was in the sitting position on a chair. In order to provide relaxation in the connective tissue, the patient was asked to perform a slight anterior tilt and to hold his back upright. The middle fingers were used bilaterally in order to provide traction between the cutaneous tissues. In order to prevent contraindication, the procedure was applied to the tissues that were 2 inch away from the surgical site. Throughout the procedure, oxygen saturation of the patient, if required, the heart rate and blood pressure were followed up. The connective tissue massage was started from the lumbosacral region (baseline) and was applied to the lower thoracic, scapular, inter-scapular and cervico-occipital region according to the vascular response of the connective tissue. A total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Depending on the area of procedure, each session varied between 15 minutes and 20 minutes. On postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day (before the massage in the experimental group) (between 8.00 and 9.00 in the morning); in other words, pain level of the patients (n=54) was evaluated at every 24 hours as of the zeroth postoperative day.
Totally applied analgesic amounts of the patients were recorded on the postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day. In addition, length of hospitalization of the patients was recorded.In the present study, it was found that the patients with prolonged hospitalization period had higher postoperative pain and the duration of hospitalization was longer in the control group. It was thought that this difference was caused by the effects of connective tissue massage on pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue massage gruop | Experimental | Other: MassageIn addition, a total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Connective tissue massage was only performed to the patients in the experimental group. A total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Depending on the area of procedure, each session varied between 15 minutes and 20 minutes. |
| Conventional Physiotherapy and Rehabilitation Group | No intervention | –Standard medical treatment, care and pulmonary rehabilitation program were applied to bonventional Physiotherapy and Rehabilitation Group.The patients were mobilized as early as possible. Starting on the postoperative zeroth day, a postoperative rehabilitation program including pulmonary rehabilitation and early mobilization was applied to every patient in the control and experimental groups by a therapist for 1 week as in routine |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Applying to Thoracic Surgery Department of Akdeniz University Hospital and undergoing thoracotomy via posterolateral thoracotomy incision,
- Being in age range of 20-75 years,
- Being stable in terms of hemodynamics,
- Having no metastatic dissemination,
- Having no known cerebrovascular disease,
Key exclusion criteria (5 listed)
- Having cardiovascular diseases,
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 |
|---|---|---|
| MassageThe connective tissue massage was started from the lumbosacral region (baseline) and was applied to the lower thoracic, scapular, inter-scapular and cervico-occipital region according to the vascular response of the connective tissue. | Other | Connective tissue massage gruop |
Primary outcome
Change of Pain Score
Time frame: Change from Baseline Pain Score at 7 days.
On postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day (before the massage in the experimental group) (between 8.00 and 9.00 in the morning); in other words, pain level of the patients (n=54) was evaluated at every 24 hours as of the zeroth postoperative day.
Change of applied analgesic amounts of the patients
Time frame: Change from Baseline applied analgesic amounts of the patients at 7 days.
Totally applied analgesic amounts of the patients were recorded on the postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day. In addition, length of hospitalization of the patients was recorded.
3 secondary outcomes
Height in Meters
Time frame: Initial assessment before surgery.
Weight in Kilograms
Time frame: Initial assessment before surgery.
Body Mass Index (BMI) in kg/m^2
Time frame: Initial assessment before surgery.
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 16 Nov 2022.
- 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.
Neriman Aksu principal investigator
Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu
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 Postoperative Pain, run by Akdeniz 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 10 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 16 Nov 2022. 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?
Change of Pain Score (time frame: Change from Baseline Pain Score at 7 days.). 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 16 Nov 2022.