First PregnancytouchNCT04543487
Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
A study testing Therapeutic touch in people with First Pregnancy and Vaginal Delivery, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Touching ensures physical, emotional and spiritual relaxation, confidence, peace, calmness and well-being, and increases self-esteem. The aim of this study is to determine the effect of therapeutic touch on labour pain, anxiety and childbirth attitude. Read more about this study
- Who is it for?
- Ages 19 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- First Pregnancy, Vaginal Delivery
- What is being tested?
- Therapeutic touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 Dec 2019
- 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 19 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a first pregnancy
- 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 receiving infertility treatment
- Not having a chronic physical or psychiatric diagnosis
- Agreeing to participate in the research
Who cannot join
- -Multiparity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
Introduction: Touching ensures physical, emotional and spiritual relaxation, confidence, peace, calmness and well-being, and increases self-esteem. The aim of this study is to determine the effect of therapeutic touch on labour pain, anxiety and childbirth attitude.
Methods: The sample of this randomized controlled experimental research consisted of 80 (intervention group: 40; control group: 40) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Childbirth Attitudes Questionnaire.
- Conditions
- First Pregnancy, Vaginal Delivery
- Being tested
- Therapeutic touch
- Keywords
- therapeutic touch, labour pain, anxiety, childbirth attitude
- 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 touchOther
Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the active phase of the first stage of labour, and the second was done in the second stage of labour.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Group name Receives: Other: Therapeutic touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
It is used to assess pain intensity. The scale is graded from 0 to 10 cm in length, where 0 represents no pain and 10 represents the most severe pain. It is applied by having the individual mark a point corresponding to the intensity of the pain they feel. The distance between the marked point and the lowest end of the line is measured in centimeters, and the resulting numerical value indicates the patient's pain intensity.
Measured: Baseline
State Anxiety Inventory
The inventory consists of four-degree evaluations ranging from "Not at all" to "Completely" in the Likert type. There are 20 items in the inventory, and the individual is required to define how he/she feels at a certain moment and under certain conditions, and to respond by taking into account his/her feelings about the situation he/she is in. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.
Measured: Baseline
Childbirth Attitudes Questionnaire
This scale four-point Likert-type questionnaire consists of 16 items and high scores indicate greater anxiety. Scale scores are calculated by taking the average of the 16 items. The items on the scale are scored as follows: "1 = No anxiety ", "2 = Low anxiety ", "3 = Moderate anxiety " and "4 = High anxiety ". Each item on the scale is scored between 1 and 4.
Measured: Baseline
Secondary outcomes (3)
Visual Analogue Scale
It is used to assess pain intensity. The scale is graded from 0 to 10 cm in length, where 0 represents no pain and 10 represents the most severe pain. It is applied by having the individual mark a point corresponding to the intensity of the pain they feel. The distance between the marked point and the lowest end of the line is measured in centimeters, and the resulting numerical value indicates the patient's pain intensity.
Measured: In the final stage of labor
State Anxiety Inventory
The inventory consists of four-degree evaluations ranging from "Not at all" to "Completely" in the Likert type. There are 20 items in the inventory, and the individual is required to define how he/she feels at a certain moment and under certain conditions, and to respond by taking into account his/her feelings about the situation he/she is in. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.
Measured: In the final stage of labor
Childbirth Attitudes Questionnaire
This scale four-point Likert-type questionnaire consists of 16 items and high scores indicate greater anxiety. Scale scores are calculated by taking the average of the 16 items. The items on the scale are scored as follows: "1 = No anxiety ", "2 = Low anxiety ", "3 = Moderate anxiety " and "4 = High anxiety ". Each item on the scale is scored between 1 and 4.
Measured: In the final stage of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jul 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Ertekin Pinar, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543487
- Sponsor's protocol ID
- TR SIVAS01
- Acronym
- touch
- Status last verified
- Sep 2020
- First submitted
- 25 Aug 2020
- Last updated
- 20 Feb 2026
- 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
- ClinicalTrials.gov ID
- NCT04543487
- Acronym / sponsor ID
- touch / TR SIVAS01
- Conditions
- First Pregnancy, Vaginal Delivery
- Keywords
- therapeutic touch, labour pain, anxiety, childbirth attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 10 Sep 2020 (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.
Introduction: Touching ensures physical, emotional and spiritual relaxation, confidence, peace, calmness and well-being, and increases self-esteem. The aim of this study is to determine the effect of therapeutic touch on labour pain, anxiety and childbirth attitude.
Methods: The sample of this randomized controlled experimental research consisted of 80 (intervention group: 40; control group: 40) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Childbirth Attitudes Questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Therapeutic touchGroup name |
Who may qualify
- Ages
- 19 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Having a first pregnancy
- 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
Key exclusion criteria (1 listed)
- -Multiparity
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 touchTherapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the active phase of the first stage of labour, and the second was done in the second stage of labour. | Other | Control Group |
Primary outcome
Visual Analogue Scale
Time frame: Baseline
It is used to assess pain intensity. The scale is graded from 0 to 10 cm in length, where 0 represents no pain and 10 represents the most severe pain. It is applied by having the individual mark a point corresponding to the intensity of the pain they feel. The distance between the marked point and the lowest end of the line is measured in centimeters, and the resulting numerical value indicates the patient's pain intensity.
State Anxiety Inventory
Time frame: Baseline
The inventory consists of four-degree evaluations ranging from "Not at all" to "Completely" in the Likert type. There are 20 items in the inventory, and the individual is required to define how he/she feels at a certain moment and under certain conditions, and to respond by taking into account his/her feelings about the situation he/she is in. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.
Childbirth Attitudes Questionnaire
Time frame: Baseline
This scale four-point Likert-type questionnaire consists of 16 items and high scores indicate greater anxiety. Scale scores are calculated by taking the average of the 16 items. The items on the scale are scored as follows: "1 = No anxiety ", "2 = Low anxiety ", "3 = Moderate anxiety " and "4 = High anxiety ". Each item on the scale is scored between 1 and 4.
3 secondary outcomes
Visual Analogue Scale
Time frame: In the final stage of labor
State Anxiety Inventory
Time frame: In the final stage of labor
Childbirth Attitudes Questionnaire
Time frame: In the final stage of labor
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
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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 in people with First 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 8 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.