Therapeutic TouchNCT06062160
The Effect of Therapeutic Touch on Pain and Comfort After Cesarean Section
A study testing Therapeutic Touch in people with Therapeutic Touch and Postpartum Period, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Touch, Postpartum Period, Midwifery
- What is being tested?
- Therapeutic Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Those between the ages of 18 and 45
- Multiparous women
- At the 8th postoperative hour
- Women who have not developed any complications during pregnancy, birth and postpartum for themselves or their newborns.
- Having a single, healthy newborn at term,
- Does not react negatively to any attempt to touch,
- Able to speak and communicate in Turkish
- Agreeing to participate in the study
Who cannot join
- Those with any problems diagnosed before or at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
- Those who develop any complications related to mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.).
- Those who receive different analgesics other than routine post-operative analgesics (75 mg diclofenac sodium in the first 30 minutes post-op).
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.
Read the detailed description
Cesarean section rate is increasing in the world and in our country, and it might bring other problems with it. Pain, breastfeeding problems and decrease in comfort problems have high chance to happen after cesarean section. The insufficiency of pharmacological methods in reducing the problems experienced after cesarean section and having many side effects increase the using percentage tendency to non-pharmacological methods.
This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.
- Conditions
- Therapeutic Touch, Postpartum Period, Midwifery, Comfort
- Being tested
- Therapeutic Touch
- Keywords
- Therapeutic Touch, comfort, midwifery, pain, postpartum period
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchOther
Experimental group received deep Therapeutic Touch two time at 10th and 40nd hours after cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental group received deep Therapeutic Touch two time at 10th and 40nd hours after cesarean section. Receives: Other: Therapeutic Touch |
| Control | No intervention | There will be no intervention in the control group. Routine maintenance will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The scale is scored between 0-10 points. As the score increases, the pain increases.
Measured: Measurement was taken half an hour after the intervention.
Postpartum Comfort Scale
The scale is scored between 34 and 170 points. As the score increases, comfort increases.
Measured: Measurement was taken half an hour 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 posted2 Oct 2023
- Study start1 Jan 2022
- Primary completion30 Sep 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic TouchStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There is a difference between the posttest pain scores of the intervention group and the control group. There is a difference between the comfort level posttest scores of the intervention group and the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Akbaş, Cukurova University
- Investigators
- Meltem Akbaş, PhD, Principal investigator, Universty Of Cukurova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062160
- Sponsor's protocol ID
- 10.09.2021/114
- Status last verified
- Feb 2025
- First submitted
- 20 Sep 2023
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Touch on Pain and Comfort After Cesarean Section
- ClinicalTrials.gov ID
- NCT06062160
- Acronym / sponsor ID
- 10.09.2021/114
- Conditions
- Therapeutic Touch, Postpartum Period, Midwifery, Comfort
- Keywords
- Therapeutic Touch, comfort, midwifery, pain, postpartum period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 2 Oct 2023 (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 study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.
Detailed description
Cesarean section rate is increasing in the world and in our country, and it might bring other problems with it. Pain, breastfeeding problems and decrease in comfort problems have high chance to happen after cesarean section. The insufficiency of pharmacological methods in reducing the problems experienced after cesarean section and having many side effects increase the using percentage tendency to non-pharmacological methods.
This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There is a difference between the posttest pain scores of the intervention group and the control group. There is a difference between the comfort level posttest scores of the intervention group and the control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Therapeutic TouchExperimental group received deep Therapeutic Touch two time at 10th and 40nd hours after cesarean section. |
| Control | No intervention | –There will be no intervention in the control group. Routine maintenance will be given. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Those between the ages of 18 and 45
Key exclusion criteria (3 listed)
- Those with any problems diagnosed before or at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
- Those who develop any complications related to mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.).
- Those who receive different analgesics other than routine post-operative analgesics (75 mg diclofenac sodium in the first 30 minutes post-op).
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 |
|---|---|---|
| Therapeutic TouchExperimental group received deep Therapeutic Touch two time at 10th and 40nd hours after cesarean section. | Other | Experimental |
Primary outcome
Visual Analog Scale
Time frame: Measurement was taken half an hour after the intervention.
The scale is scored between 0-10 points. As the score increases, the pain increases.
Postpartum Comfort Scale
Time frame: Measurement was taken half an hour after the intervention.
The scale is scored between 34 and 170 points. As the score increases, comfort increases.
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 19 Feb 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.
Meltem Akbaş, PhD principal investigator
Universty Of Cukurova
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 in people with Therapeutic Touch and Postpartum Period, 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 8 inclusion and 3 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 19 Feb 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?
Visual Analog Scale (time frame: Measurement was taken half an hour 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 19 Feb 2025.