Primiparous Mothers Who Gave Birth by Cesarean SectionNCT05521581
Effects Of Hand Massage After Cesarean Section
A study testing Hand massage in people with Primiparous Mothers Who Gave Birth by Cesarean Section, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
H1-1 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the level of pain in the cesarean section incision area of women. H1-2 Hypothesis: Hand massage applied after cesarean delivery has an effect on increasing the comfort scale score of women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primiparous Mothers Who Gave Birth by Cesarean Section
- What is being tested?
- Hand massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2022to 25 Mar 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having primiparous pregnancy,
- 18 years old and over,
- Able to speak Turkish and express himself in Turkish,
- Does not have any disability (such as vision, hearing)
- Having completed the 6th hour after cesarean delivery, hospitalized in the gynecology service,
- Having undergone cesarean section with spinal anesthesia,
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- Having no findings such as wounds, nerve problems, history of surgery or amputation on their hands,
- Single pregnancy,
- Women who are open to communication and who are mentally and physically healty
Who cannot join
- Not accepting to work,
- Having a gas outlet before starting the application,
- Presence of findings such as wounds on hands, nerve problems, history of surgery or amputation,
- Having postpartum hemorrhage,
- With uterine subinvolution,
- Having a cesarean section with another type of anesthesia other than spinal anesthesia (such as general, epidural combined)
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- Having twin babies,
- Having a premature baby (the baby needs more attention and care)
- Women whose babies are hospitalized in the neonatal intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF AFTER CAESARIAN SECTION HAND MASSAGE ON PAIN, COMFORT LEVEL AND GAS OUTPUT TIME
H1-1 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the level of pain in the cesarean section incision area of women.
H1-2 Hypothesis: Hand massage applied after cesarean delivery has an effect on increasing the comfort scale score of women.
H1-3 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the time of gas production in women.
- Being tested
- Hand massage
- Keywords
- hand massage, cesarean delivery, ache, comfort, gas outlet, midwife
- 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
Hand massage will be applied to primiparous mothers who gave birth by cesarean section and its effect on pain, comfort and gas release times will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Hand massage will be applied to primiparous mothers who gave birth by cesarean section Receives: Other: Hand massage |
| control | No intervention | Routine care will be given to mothers who have given cesarean section and hand massage will not be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
inclusion of women in the study and filling out the introductory information form
Women are included in the study by filling out the introductory information form. The information obtained will be recorded in the SPSS 20.0 package program.
Measured: maximum one hour
ensuring the randomization of the women included in the study into the intervention and control groups
Distributions are made to women included in the study and to control and intervention groups.
Measured: Five min
practicing and observing hand massage
Mothers assigned to the intervention group receive 2 sessions of hand massage. The first session is applied at the 6th hour after the cesarean section, and the second session is applied at the 12th hour after the cesarean section.
Routine care is applied to the control group and hand massage is not applied.
Measured: an average of 12-13 hours
assessment of pain
Women in the intervention and control groups are assessed for pain with the Visual Analog Scale (VAS).
Measured: five min
comfort assessment
Women in the intervention and control groups will be evaluated with the Postpartum Comfort Scale.
Measured: ten min
Evaluation of gas exit time
The effectiveness of hand massage will be evaluated by looking at the time between cesarean section hours and gas release times of women in the intervention and control groups.
Measured: five min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start25 Aug 2022 (estimated)
- Primary completion25 Jan 2023 (estimated)
- Study completion25 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primiparous Mothers Who Gave Birth by Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Single group
- Model description
- Single Group Assignment Women who had cesarean section in the institution were evaluated in terms of sample. They were divided into two groups as criteria and random sampling. be an order obtained a random number table, capable of random sampling automatically by means of programs on websites by specifying a number. samples. Selection of intervention and control groups determined by tossing a coin. The sample number was determined as 83 women who had a total of 166 cesarean section in each of the intervention and control groups. Considering the data losses, 10% more was calculated and it was planned to conduct the research with a total of 182 women (91 women in the intervention group, 91 women in the control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Dügeroğlu, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521581
- Sponsor's protocol ID
- SelcukU SDugeroglu071
- Status last verified
- Aug 2022
- First submitted
- 20 Aug 2022
- Last updated
- 30 Aug 2022
- 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 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF AFTER CAESARIAN SECTION HAND MASSAGE ON PAIN, COMFORT LEVEL AND GAS OUTPUT TIME
- ClinicalTrials.gov ID
- NCT05521581
- Acronym / sponsor ID
- SelcukU SDugeroglu071
- Keywords
- hand massage, cesarean delivery, ache, comfort, gas outlet, midwife
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 25 Aug 2022 (estimated)
- Primary completion
- 25 Jan 2023 (estimated)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 30 Aug 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.
H1-1 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the level of pain in the cesarean section incision area of women.
H1-2 Hypothesis: Hand massage applied after cesarean delivery has an effect on increasing the comfort scale score of women.
H1-3 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the time of gas production in women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Group Assignment Women who had cesarean section in the institution were evaluated in terms of sample. They were divided into two groups as criteria and random sampling. be an order obtained a random number table, capable of random sampling automatically by means of programs on websites by specifying a number. samples. Selection of intervention and control groups determined by tossing a coin. The sample number was determined as 83 women who had a total of 166 cesarean section in each of the intervention and control groups. Considering the data losses, 10% more was calculated and it was planned to conduct the research with a total of 182 women (91 women in the intervention group, 91 women in the control group).
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Hand massageHand massage will be applied to primiparous mothers who gave birth by cesarean section |
| control | No intervention | –Routine care will be given to mothers who have given cesarean section and hand massage will not be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Having primiparous pregnancy,
- 18 years old and over,
- Able to speak Turkish and express himself in Turkish,
- Does not have any disability (such as vision, hearing)
- Having completed the 6th hour after cesarean delivery, hospitalized in the gynecology service,
Key exclusion criteria (9 listed)
- Not accepting to work,
- Having a gas outlet before starting the application,
- Presence of findings such as wounds on hands, nerve problems, history of surgery or amputation,
- Having postpartum hemorrhage,
- With uterine subinvolution,
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 massageHand massage will be applied to primiparous mothers who gave birth by cesarean section and its effect on pain, comfort and gas release times will be evaluated. | Other | intervention |
Primary outcome
inclusion of women in the study and filling out the introductory information form
Time frame: maximum one hour
Women are included in the study by filling out the introductory information form. The information obtained will be recorded in the SPSS 20.0 package program.
ensuring the randomization of the women included in the study into the intervention and control groups
Time frame: Five min
Distributions are made to women included in the study and to control and intervention groups.
practicing and observing hand massage
Time frame: an average of 12-13 hours
Mothers assigned to the intervention group receive 2 sessions of hand massage. The first session is applied at the 6th hour after the cesarean section, and the second session is applied at the 12th hour after the cesarean section. Routine care is applied to the control group and hand massage is not applied.
assessment of pain
Time frame: five min
Women in the intervention and control groups are assessed for pain with the Visual Analog Scale (VAS).
comfort assessment
Time frame: ten min
Women in the intervention and control groups will be evaluated with the Postpartum Comfort Scale.
Evaluation of gas exit time
Time frame: five min
The effectiveness of hand massage will be evaluated by looking at the time between cesarean section hours and gas release times of women in the intervention and control groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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 Primiparous Mothers Who Gave Birth by Cesarean Section, run by Selcuk 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 9 inclusion and 9 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 30 Aug 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?
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?
inclusion of women in the study and filling out the introductory information form (time frame: maximum one hour). The study lists 6 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 30 Aug 2022.