PregnancyNCT06426329
The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety
A study testing Therapeutic Touch in people with Pregnancy and Vaginal Delivery, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was planned to determine the effect of therapeutic touch applied at birth on pain, birth duration, traumatic birth perception and anxiety. 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
- Pregnancy, Vaginal Delivery
- What is being tested?
- Therapeutic Touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jan 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not having a high-risk pregnancy Having no health problems with the baby or herself Having a single foetus Being about to have a vaginal delivery Not having a chronic physical or psychiatric diagnosis Agreeing to participate in the research Not having communication and perception problems Miad (37W<) pregnancy Having with induction application
Who cannot join
- having vacuum, forceps etc. intervention such as
Trial locations and contacts
1 site in 1 country.
About this study
Aim: This study was planned to determine the effect of therapeutic touch applied at birth on pain, birth duration, traumatic birth perception and anxiety.
Read the detailed description
Methods: The sample of this randomized controlled experimental research consisted of 66 (intervention group: 33; control group: 33) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Traumatic Childbirth Perception Scale.
- Conditions
- Pregnancy, Vaginal Delivery
- Being tested
- Therapeutic Touch
- Keywords
- Therapeutic Touch, Labor Pain, Birth Duration, Anxiety, Traumatic Birth Perception
- Medical subject headings
- Labor Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchBehavioural
Also called Control Group
Therapeutic touch, as meaningful touch, is included in complementary medicine in the literature. It provides physical, emotional and spiritual relief, improves physiological health, makes the person feel valuable, gives confidence, peace, calmness and increases self-confidence.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic touch Group | Experimental | Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the latent phase of the first stage of labour, and the second was done in the active phase of labour. Receives: Behavioral: Therapeutic Touch |
| Standard of care Group | No intervention | The control group did not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain.
Measured: Baseline
State Anxiety Inventory
It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety".
Measured: Baseline
Traumatic Birth Perception Scale
It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth
Measured: Baseline
Secondary outcomes (3)
Visual Analogue Scale
It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain.
Measured: Postpartum in 2 hour
State Anxiety Inventory
It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety".
Measured: Postpartum in 2 hour
Traumatic Birth Perception Scale
It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth
Measured: Postpartum in 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Jan 2024
- Primary completion30 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Ertekin Pinar, Cumhuriyet University
- Investigators
- Sukran Ertekin Pinar, Ph.D., Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426329
- Sponsor's protocol ID
- TR SİVAS 04
- Status last verified
- Jan 2024
- First submitted
- 27 Mar 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety
- ClinicalTrials.gov ID
- NCT06426329
- Acronym / sponsor ID
- TR SİVAS 04
- Conditions
- Pregnancy, Vaginal Delivery
- Keywords
- Therapeutic Touch, Labor Pain, Birth Duration, Anxiety, Traumatic Birth Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 23 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.
Aim: This study was planned to determine the effect of therapeutic touch applied at birth on pain, birth duration, traumatic birth perception and anxiety.
Detailed description
Methods: The sample of this randomized controlled experimental research consisted of 66 (intervention group: 33; control group: 33) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Traumatic Childbirth Perception Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic touch Group | Experimental | Behavioral: Therapeutic TouchTherapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the latent phase of the first stage of labour, and the second was done in the active phase of labour. |
| Standard of care Group | No intervention | –The control group did not receive any treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Not having a high-risk pregnancy Having no health problems with the baby or herself Having a single foetus Being about to have a vaginal delivery Not having a chronic physical or psychiatric diagnosis Agreeing to participate in the research Not having communication and perception problems Miad (37W<) pregnancy Having with induction application
Key exclusion criteria (1 listed)
- having vacuum, forceps etc. intervention such as
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 TouchAlso: Control GroupTherapeutic touch, as meaningful touch, is included in complementary medicine in the literature. It provides physical, emotional and spiritual relief, improves physiological health, makes the person feel valuable, gives confidence, peace, calmness and increases self-confidence. | Behavioural | Therapeutic touch Group |
Primary outcome
Visual Analogue Scale
Time frame: Baseline
It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain.
State Anxiety Inventory
Time frame: Baseline
It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety".
Traumatic Birth Perception Scale
Time frame: Baseline
It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth
3 secondary outcomes
Visual Analogue Scale
Time frame: Postpartum in 2 hour
State Anxiety Inventory
Time frame: Postpartum in 2 hour
Traumatic Birth Perception Scale
Time frame: Postpartum in 2 hour
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 20 Feb 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Sukran Ertekin Pinar, Ph.D. principal investigator
Cumhuriyet University
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 Pregnancy and Vaginal Delivery, run by Cumhuriyet 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 1 inclusion and 1 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 20 Feb 2026. 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 Analogue Scale (time frame: Baseline). The study lists 3 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 20 Feb 2026.