Therapeutic AgalactiaNCT06467188
Turkish Validity and Reliability of the Haptotherapeutic Well-Being Scale
An observational study of Therapeutic Agalactia, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: Haptotherapy fosters a sense of unity between the body, mind, and emotions. In addition, it contributes to expanding the woman's perception of her pregnancy and developing a more positive attitude towards pregnancy and childbirth. 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
- Therapeutic Agalactia
- What is being tested?
- Validity and reliability
- How many people
- 252 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2023to 20 Dec 2023
- Phase
- Observational
- 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
Study population: Women over 18 age, living in Turkiye, using social media (Facebook, Instagram), and agreeing to participate in the study
Who may be able to join
- Women over 18 age, living in Turkiye, using social media (Facebook, Instagram), and agreeing to participate in the study.
Who cannot join
- Women who were illiterate in Turkish, had hearing-vision problems or mental disabilities, did not have social media (Facebook, Instagram), and did not volunteer to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: Haptotherapy fosters a sense of unity between the body, mind, and emotions. In addition, it contributes to expanding the woman's perception of her pregnancy and developing a more positive attitude towards pregnancy and childbirth. The study aims to examine the Turkish validity and reliability of the Haptotherapeutic Well-Being Scale, which will be used to evaluate the well-being levels of haptonomy and haptotherapy practices in women.
Design: The study was methodological type. Methods: The study conducted between October 20 and December 20, 2023, with 242 women who volunteered to participate by sharing forum pages on social media (Facebook, Instagram) via the web. Data were collected using a personal information form, including sociodemographic and obstetric characteristics and the Haptotherapeutic Well-Being Scale.
- Conditions
- Therapeutic Agalactia
- Being tested
- Validity and reliability
- Keywords
- Haptonomy, Validity, Reliability, Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validity and reliabilityOther
In order to evaluate the content validity of the Turkish version of the scale, 12 expert researchers in the field of gynecology and obstetrics were consulted. The experts were asked to evaluate the items as 1-Not Appropriate, 2-Somewhat Appropriate, 3-Reasonably Appropriate, and 4-Very Appropriate. Experts were asked to suggest items not evaluated as "very appropriate". In the Davis technique, the content validity index which is calculated by dividing the number of experts who marked the options a (The item is appropriate) and b (The item needs minor revision) for each item by the total number of experts providing opinions is expected to be over 0.80 [30]. Based on expert opinions, the content validity index (CVI) value of the scale was calculated to be 96%, meaning that content validity was ensured. The items were reorganized by considering the experts' suggestions. The scale was administered to 252 women over 18 who were included in the study sample after scoring.
What is being measured
The primary outcome is the main question the study is designed to answer.
Haptotherapeutic Well-Being Scale
Scale consists of 14 items and five sub-dimensions. High scores obtained from the scale mean that the level of haptotherapeutic well-being is also good. There are are received that the minimum 4, maximum 20 points from the psychological well-being sub-dimension, minimum 2, maximum 10 points from the physical health sub-dimension, minimum 3, maximum 15 points from the autonomy, relationships with others and touching and being touched sub-dimensions.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start20 Oct 2023
- Primary completion20 Oct 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic AgalactiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467188
- Sponsor's protocol ID
- 14.09.2023-14
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kucukkaya B, Isik HK, Rathfisch G. Turkish validity and reliability of the Haptotherapeutic Well-Being Scale. BMC Complement Med Ther. 2024 Aug 30;24(1):323. doi: 10.1186/s12906-024-04613-z.
PubMed 39215291
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Haptotherapeutic Well-Being Scale
- ClinicalTrials.gov ID
- NCT06467188
- Acronym / sponsor ID
- 14.09.2023-14
- Conditions
- Therapeutic Agalactia
- Keywords
- Haptonomy, Validity, Reliability, Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 20 Jun 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.
Objectives: Haptotherapy fosters a sense of unity between the body, mind, and emotions. In addition, it contributes to expanding the woman's perception of her pregnancy and developing a more positive attitude towards pregnancy and childbirth. The study aims to examine the Turkish validity and reliability of the Haptotherapeutic Well-Being Scale, which will be used to evaluate the well-being levels of haptonomy and haptotherapy practices in women.
Design: The study was methodological type. Methods: The study conducted between October 20 and December 20, 2023, with 242 women who volunteered to participate by sharing forum pages on social media (Facebook, Instagram) via the web. Data were collected using a personal information form, including sociodemographic and obstetric characteristics and the Haptotherapeutic Well-Being Scale.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18 age, living in Turkiye, using social media (Facebook, Instagram), and agreeing to participate in the study
Key inclusion criteria (1 listed)
- Women over 18 age, living in Turkiye, using social media (Facebook, Instagram), and agreeing to participate in the study.
Key exclusion criteria (1 listed)
- Women who were illiterate in Turkish, had hearing-vision problems or mental disabilities, did not have social media (Facebook, Instagram), and did not volunteer to participate.
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 |
|---|---|---|
| Validity and reliabilityIn order to evaluate the content validity of the Turkish version of the scale, 12 expert researchers in the field of gynecology and obstetrics were consulted. The experts were asked to evaluate the items as 1-Not Appropriate, 2-Somewhat Appropriate, 3-Reasonably Appropriate, and 4-Very Appropriate. Experts were asked to suggest items not evaluated as "very appropriate". In the Davis technique, the content validity index which is calculated by dividing the number of experts who marked the options a (The item is appropriate) and b (The item needs minor revision) for each item by the total number of experts providing opinions is expected to be over 0.80 [30]. Based on expert opinions, the content validity index (CVI) value of the scale was calculated to be 96%, meaning that content validity was ensured. The items were reorganized by considering the experts' suggestions. The scale was administered to 252 women over 18 who were included in the study sample after scoring. | Other | – |
Primary outcome
Haptotherapeutic Well-Being Scale
Time frame: 1 day
Scale consists of 14 items and five sub-dimensions. High scores obtained from the scale mean that the level of haptotherapeutic well-being is also good. There are are received that the minimum 4, maximum 20 points from the psychological well-being sub-dimension, minimum 2, maximum 10 points from the physical health sub-dimension, minimum 3, maximum 15 points from the autonomy, relationships with others and touching and being touched sub-dimensions.
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 21 Jun 2024.
- Derived from this study: PubMed 39215291Kucukkaya B, Isik HK, Rathfisch G. Turkish validity and reliability of the Haptotherapeutic Well-Being Scale. BMC Complement Med Ther. 2024 Aug 30;24(1):323. doi: 10.1186/s12906-024-04613-z.
- 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?
An observational study of Therapeutic Agalactia, run by Trakya 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 21 Jun 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?
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?
Haptotherapeutic Well-Being Scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06467188, which also lists 1 linked publication.
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 21 Jun 2024.