SleepNCT06403566
THE EFFECT OF HAND AND BACK MASSAGE ON PAIN, SLEEP AND SELF-CARE IN WOMEN UNDERGOING HYSTERECTOMY
A study testing hand massage in people with Sleep and Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative incision pain is an acute pain that begins with the stimulation of neuroreceptors from surgical trauma and usually resolves within a few days. Today, the physiology of acute pain is better understood and new approaches to pain management are emerging. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Pain, Self Efficacy
- What is being tested?
- hand massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jun 2025
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 25-65,
- Elective surgery,
- Lying in the hospital for at least 2 days after surgery,
- Operated under general anesthesia
Who cannot join
- No serious complications developed after surgery,
- Never had a back or hand massage before,
- Cognitive, effective and without any problem preventing communication,
- No psychiatric problems,
- Patients receiving a single type of analgesic drug (non-narcotic analgesics) to ensure homogeneity of the groups and to increase the reliability of the study results,
- Patients not using Patient Controlled Analgesia (PCA) will be included in the sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF HAND AND BACK MASSAGE ON PAIN, SLEEP AND SELF-CARE IN WOMEN UNDERGOING HYSTERECTOMY: A RANDOMIZED CONTROLLED TRIAL
Postoperative incision pain is an acute pain that begins with the stimulation of neuroreceptors from surgical trauma and usually resolves within a few days. Today, the physiology of acute pain is better understood and new approaches to pain management are emerging. However, studies conducted in recent years have reported that postoperative pain management is inadequate, and therefore approximately 50-80% of patients still experience moderate to severe pain
Read the detailed description
Self-care is the realization of health activities to maintain one's health, life and well-being (14). Self-care power is at different levels in each person and perceptual, cognitive, interpersonal and psychomotor characteristics are needed for an effective self-care power to be formed. Therefore, self-care power varies according to the ability and health status of the individual (12). According to Orem, the development and maintenance of health are the results to be obtained through self-care. Orem's theory also "values personal responsibility for health and indicates that nursing services may have a key role in prevention and health education". Since self-care is a learnable behavior, nurses can encourage and support people's self-care efforts and increase the individual's participation by providing health education (12).
When the literature is examined, there are a limited number of studies examining the effect of back massage on pain in women undergoing hysterectomy surgery. There are studies examining the effect of reiki on pain in different fields (13,14). Pain is a condition that affects all dimensions of the individual including biophysiologic, psychological, sociocultural and political-economic. Although analgesics are indispensable to alleviate postoperative pain, undesirable effects may occur when overused. Therefore, nurses' use of non-drug methods in addition to pharmacologic methods will increase the effectiveness of pharmacologic methods (15). Pharmacology
- Conditions
- Sleep, Pain, Self Efficacy
- Being tested
- hand massage
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand massageOther
Also called back massage
three group randomized controlled trials
| Study group | Role | What they receive |
|---|---|---|
| hand massage application | Experimental | hand massage will be applied before and after surgery Receives: Other: hand massage |
| back massage application | Active comparator | back massage will be applied before and after surgery Receives: Other: hand massage |
| control group | No intervention | no intervention will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand massage
hand massage reduces women's pain score 0-10 points
Measured: will be checked on the 2nd postoperative day
back massage
back massage women's pain score 76-100 points
Measured: will be checked on the 2nd postoperative day
hand massage
hand massage improves women's scores by reducing sleep problems
Measured: will be checked on the 2nd postoperative day
back massage
back massage improves women's scores by reducing sleep problems
Measured: will be checked on the 2nd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seda karaçay yıkar, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403566
- Sponsor's protocol ID
- 139-43
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF HAND AND BACK MASSAGE ON PAIN, SLEEP AND SELF-CARE IN WOMEN UNDERGOING HYSTERECTOMY: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT06403566
- Acronym / sponsor ID
- 139-43
- Conditions
- Sleep, Pain, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 May 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.
Postoperative incision pain is an acute pain that begins with the stimulation of neuroreceptors from surgical trauma and usually resolves within a few days. Today, the physiology of acute pain is better understood and new approaches to pain management are emerging. However, studies conducted in recent years have reported that postoperative pain management is inadequate, and therefore approximately 50-80% of patients still experience moderate to severe pain
Detailed description
Self-care is the realization of health activities to maintain one's health, life and well-being (14). Self-care power is at different levels in each person and perceptual, cognitive, interpersonal and psychomotor characteristics are needed for an effective self-care power to be formed. Therefore, self-care power varies according to the ability and health status of the individual (12). According to Orem, the development and maintenance of health are the results to be obtained through self-care. Orem's theory also "values personal responsibility for health and indicates that nursing services may have a key role in prevention and health education". Since self-care is a learnable behavior, nurses can encourage and support people's self-care efforts and increase the individual's participation by providing health education (12).
When the literature is examined, there are a limited number of studies examining the effect of back massage on pain in women undergoing hysterectomy surgery. There are studies examining the effect of reiki on pain in different fields (13,14). Pain is a condition that affects all dimensions of the individual including biophysiologic, psychological, sociocultural and political-economic. Although analgesics are indispensable to alleviate postoperative pain, undesirable effects may occur when overused. Therefore, nurses' use of non-drug methods in addition to pharmacologic methods will increase the effectiveness of pharmacologic methods (15). Pharmacology
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hand massage application | Experimental | Other: hand massagehand massage will be applied before and after surgery |
| back massage application | Active comparator | Other: hand massageback massage will be applied before and after surgery |
| control group | No intervention | –no intervention will be made |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range 25-65,
- Elective surgery,
- Lying in the hospital for at least 2 days after surgery,
- Operated under general anesthesia
Key exclusion criteria (6 listed)
- No serious complications developed after surgery,
- Never had a back or hand massage before,
- Cognitive, effective and without any problem preventing communication,
- No psychiatric problems,
- Patients receiving a single type of analgesic drug (non-narcotic analgesics) to ensure homogeneity of the groups and to increase the reliability of the study results,
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 |
|---|---|---|
| hand massageAlso: back massagethree group randomized controlled trials | Other | back massage application, hand massage application |
Primary outcome
hand massage
Time frame: will be checked on the 2nd postoperative day
hand massage reduces women's pain score 0-10 points
back massage
Time frame: will be checked on the 2nd postoperative day
back massage women's pain score 76-100 points
hand massage
Time frame: will be checked on the 2nd postoperative day
hand massage improves women's scores by reducing sleep problems
back massage
Time frame: will be checked on the 2nd postoperative day
back massage improves women's scores by reducing sleep problems
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Healthy Adult Participants
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 hand massage in people with Sleep and Pain, run by Cukurova 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 4 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
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?
hand massage (time frame: will be checked on the 2nd postoperative day). 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 8 May 2024.