Massage TherapyNCT07100015
The Effect of Shoulder Massage and Therapeutic Touch on Pain and Anxiety After Laparoscopic Cholecystectomy
A study testing therapeutic touch and Shoulder massage in people with Massage Therapy and Pain, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial compared the effects of shoulder massage and therapeutic touch on pain and anxiety after laparoscopic cholecystectomy. Both interventions significantly reduced pain and anxiety levels compared to the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Massage Therapy, Pain, Anxiety
- What is being tested?
- therapeutic touch and Shoulder massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2024to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were expected to be able to speak Turkish and have normal verbal communication skills.
- They were required to possess normal cognitive abilities and have no psychiatric diagnoses.
- Patients aged between 18 and 70 years.
- Patients undergoing general anesthesia.
- Patients who voluntarily agree to participate in the research
Who cannot join
- Patients receiving epidural analgesia post-surgery.
- Patients whose laparoscopic cholecystectomy (LC) procedure was converted to an open cholecystectomy during the operation.
- Patients experiencing postoperative confusion, requiring intensive care, or developing secondary complications that impair their ability to respond to questions accurately.
- Patients who do not report shoulder pain following surgery.
- Patients in a catabolic state, those aged 70 years or older, individuals with chronic pain or opioid use, and those experiencing severe postoperative symptoms such as excessive nausea, vomiting, bleeding, or infection.
- Patients with surgical drains (e.g., Hemovac) may negatively influence pain levels and sleep quality, thereby interfering with the effectiveness of the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Shoulder Massage and Therapeutic Touch on Pain and Anxiety After Laparoscopic Cholecystectomy: A Three-Arm Single-Blind Randomized Controlled Trial
This randomized controlled trial compared the effects of shoulder massage and therapeutic touch on pain and anxiety after laparoscopic cholecystectomy. Both interventions significantly reduced pain and anxiety levels compared to the control group. Shoulder massage was more effective in reducing pain, while therapeutic touch was more effective in reducing anxiety. These methods are recommended for broader use in clinical practice.
Read the detailed description
Background: Laparoscopic cholecystectomy (LC) is a frequently preferred surgical method for treating gallstones. Non-pharmacologic approaches have an important place in addition to pharmacologic treatment methods. Methods such as massage and therapeutic touch are included in the literature as effective alternatives to reduce pain and anxiety.
Aim: This study aimed to compare the effects of shoulder massage and therapeutic touch on shoulder pain and anxiety after laparoscopic cholecystectomy.
Methods: The study was a three-arm randomized controlled trial. After baseline assessment, participants were randomly assigned to three groups; random assignment was done using the Microsoft Excel 2016 program. Participants were divided into three groups: Group 1 (n=24), in which shoulder massage was applied, Group 2 (n=25), in which therapeutic touch was used, and Group 3 (n=25) in which patients did not receive any treatment and received routine postoperative care in the clinic.
- Conditions
- Massage Therapy, Pain, Anxiety, Theropathic Touch
- Being tested
- Control Group, therapeutic touch, Shoulder massage
- Keywords
- Pain, anxiety,, laparoscopic cholecystectomy,, massage,, theropathic touch
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupDevice
in which patients did not receive any treatment and received routine postoperative care in the clinic
therapeutic touchDevice
Therapeutic touch applications
Shoulder massageDevice
shoulder massage was applied
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | in which patients did not receive any treatment and received routine postoperative care in the clinic. Receives: Device: Control Group |
| Therapeutic touch | Experimental | in which therapeutic touch was applied Receives: Device: therapeutic touch |
| Shoulder massage group | Experimental | in which shoulder massage was applied Receives: Device: Shoulder massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
For shoulder pain: Measured with the Visual Analog Scale (VAS).
Shoulder Pain Intensity Assessed by Visual Analog Scale (VAS)
Measured: four month
For anxiety: The State-Trait Anxiety Inventory (STAI) was used.
State-Trait Anxiety Inventory (STAI) Score for Anxiety Assessment
Measured: four month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start17 Apr 2024
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massage TherapyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100015
- Sponsor's protocol ID
- SBFGU
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shoulder Massage and Therapeutic Touch on Pain and Anxiety After Laparoscopic Cholecystectomy: A Three-Arm Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07100015
- Acronym / sponsor ID
- SBFGU
- Conditions
- Massage Therapy, Pain, Anxiety, Theropathic Touch
- Keywords
- Pain, anxiety,, laparoscopic cholecystectomy,, massage,, theropathic touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 1 Aug 2025 (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.
This randomized controlled trial compared the effects of shoulder massage and therapeutic touch on pain and anxiety after laparoscopic cholecystectomy. Both interventions significantly reduced pain and anxiety levels compared to the control group. Shoulder massage was more effective in reducing pain, while therapeutic touch was more effective in reducing anxiety. These methods are recommended for broader use in clinical practice.
Detailed description
Background: Laparoscopic cholecystectomy (LC) is a frequently preferred surgical method for treating gallstones. Non-pharmacologic approaches have an important place in addition to pharmacologic treatment methods. Methods such as massage and therapeutic touch are included in the literature as effective alternatives to reduce pain and anxiety.
Aim: This study aimed to compare the effects of shoulder massage and therapeutic touch on shoulder pain and anxiety after laparoscopic cholecystectomy.
Methods: The study was a three-arm randomized controlled trial. After baseline assessment, participants were randomly assigned to three groups; random assignment was done using the Microsoft Excel 2016 program. Participants were divided into three groups: Group 1 (n=24), in which shoulder massage was applied, Group 2 (n=25), in which therapeutic touch was used, and Group 3 (n=25) in which patients did not receive any treatment and received routine postoperative care in the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Control Groupin which patients did not receive any treatment and received routine postoperative care in the clinic. |
| Therapeutic touch | Experimental | Device: therapeutic touchin which therapeutic touch was applied |
| Shoulder massage group | Experimental | Device: Shoulder massagein which shoulder massage was applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants were expected to be able to speak Turkish and have normal verbal communication skills.
- They were required to possess normal cognitive abilities and have no psychiatric diagnoses.
- Patients aged between 18 and 70 years.
- Patients undergoing general anesthesia.
- Patients who voluntarily agree to participate in the research
Key exclusion criteria (6 listed)
- Patients receiving epidural analgesia post-surgery.
- Patients whose laparoscopic cholecystectomy (LC) procedure was converted to an open cholecystectomy during the operation.
- Patients experiencing postoperative confusion, requiring intensive care, or developing secondary complications that impair their ability to respond to questions accurately.
- Patients who do not report shoulder pain following surgery.
- Patients in a catabolic state, those aged 70 years or older, individuals with chronic pain or opioid use, and those experiencing severe postoperative symptoms such as excessive nausea, vomiting, bleeding, or infection.
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 |
|---|---|---|
| Control Groupin which patients did not receive any treatment and received routine postoperative care in the clinic | Device | Control Group |
| therapeutic touchTherapeutic touch applications | Device | Therapeutic touch |
| Shoulder massageshoulder massage was applied | Device | Shoulder massage group |
Primary outcome
For shoulder pain: Measured with the Visual Analog Scale (VAS).
Time frame: four month
Shoulder Pain Intensity Assessed by Visual Analog Scale (VAS)
For anxiety: The State-Trait Anxiety Inventory (STAI) was used.
Time frame: four month
State-Trait Anxiety Inventory (STAI) Score for Anxiety Assessment
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 1 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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 therapeutic touch and Shoulder massage in people with Massage Therapy and Pain, run by Giresun 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 5 inclusion and 6 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 1 Aug 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?
For shoulder pain: Measured with the Visual Analog Scale (VAS). (time frame: four month). 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 1 Aug 2025.