Self-affirmation, Back MassageNCT05883501
Effect of Self-affirmation Versus Back Massage on Psychological Distress and Fear of Birth Among Primigravid Women in Third Trimester
A study testing Self-affirmation versus back massage in people with Self-affirmation, Back Massage, run by Alexandria University at 1 site in Egypt.
Trial summary
Based on the literature review, care must be emphasized on aspects of self-strengthening or self-affirmation to reduce stress and fear and equip women with the ability to manage stress and fear due to negative thoughts. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Self-affirmation, Back Massage
- What is being tested?
- Self-affirmation versus back massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 20 Oct 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Pregnant women aged 20-35 years.
- Primigravida women.
- Read \&write.
- During third trimester of pregnancy.
- Free from any medical, obstetric, gynecological and other psychological risk factors and /or conditions
- With normal course of pregnancy.
- Attend regular antenatal care visits.
- With intact back skin and free from burn, wound or any scar, injury, inflammation and allergy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing
Alexandria
Eman Taha, professor, 01283440749, eman.taha@alexu.edu.eg
About this study
Based on the literature review, care must be emphasized on aspects of self-strengthening or self-affirmation to reduce stress and fear and equip women with the ability to manage stress and fear due to negative thoughts. Accordingly, the present study aimed to investigate and compare the effects of self-affirmation versus back massage on psychological distress and fear of birth among primigravid women in third trimester.
- Conditions
- Self-affirmation, Back Massage
- Being tested
- Self-affirmation versus back massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-affirmation versus back massageBehavioural
Self-affirmation is non-pharmacological intervention which represents structured sentences to convey to the subconscious mind to help in reprogramming negative thoughts into positive ones.
Massage is defined as systematic touch of soft tissues for therapeutic purposes, such as pain relief, increased comfort and patient's relaxation
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Pregnant women will be given love cards containing positive affirmations that will be trained outside the classroom by asking the mother to practice alone once a day between waking up, before bed, or when relaxing.
The suggestions will be implanted using simple language, easy to understand, in detail, and straightforward. For example, "From now, I know how to take care of myself in pregnancy and trust in my ability to birth my baby."
Love cards will be developed through literature studies and expert tests containing positive affirmations for pregnancy and childbirth. Receives: Behavioral: Self-affirmation versus back massage |
| Group 2 | Experimental | The researcher will be used the heel of the hands, moving along the spine; using the palms moving hands with rocking movements from the top of the shoulder blade to the backbone; pressing fingertips, along both sides of the spine from the neck to the backbone and then stroking upward from the hip to the neck; stroking the shoulder muscles(trapezius); inching up the back, using fingertips placed on sides of spine, starting from the hipbone to the neck and then reversing the direction downward using fingertips in a raking fashion; massaging the lower back from the backbone across the waistline using the heel of the palm to make large circles; long gliding strokes from the hip up and over the shoulder (Nair ,. 2020 ; El-Hosary et al,. 2019).
Back massage will be done in four sessions each session takes 10 minutes and will be performed every week. Receives: Behavioral: Self-affirmation versus back massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Distress
The Kessler Psychological Distress Scale (K10) is a simple measure of psychological distress (Kessler et al., 2003). The K10 scale involves 10 questions about emotional states each with a five-level response scale. The measure can be used as a brief screen to identify levels of distress
Measured: 2 months
Fear of childbirth
The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) is a standardized screening method for measuring fear of childbirth during pregnancy (Wijma et al., 1998).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Apr 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-affirmation, Back MassageStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883501
- Sponsor's protocol ID
- 2252023
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-affirmation Versus Back Massage on Psychological Distress and Fear of Birth Among Primigravid Women in Third Trimester
- ClinicalTrials.gov ID
- NCT05883501
- Acronym / sponsor ID
- 2252023
- Conditions
- Self-affirmation, Back Massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 1 Jun 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.
Based on the literature review, care must be emphasized on aspects of self-strengthening or self-affirmation to reduce stress and fear and equip women with the ability to manage stress and fear due to negative thoughts. Accordingly, the present study aimed to investigate and compare the effects of self-affirmation versus back massage on psychological distress and fear of birth among primigravid women in third trimester.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Behavioral: Self-affirmation versus back massagePregnant women will be given love cards containing positive affirmations that will be trained outside the classroom by asking the mother to practice alone once a day between waking up, before bed, or when relaxing. The suggestions will be implanted using simple language, easy to understand, in detail, and straightforward. For example, "From now, I know how to take care of myself in pregnancy and trust in my ability to birth my baby." Love cards will be developed through literature studies and expert tests containing positive affirmations for pregnancy and childbirth. |
| Group 2 | Experimental | Behavioral: Self-affirmation versus back massageThe researcher will be used the heel of the hands, moving along the spine; using the palms moving hands with rocking movements from the top of the shoulder blade to the backbone; pressing fingertips, along both sides of the spine from the neck to the backbone and then stroking upward from the hip to the neck; stroking the shoulder muscles(trapezius); inching up the back, using fingertips placed on sides of spine, starting from the hipbone to the neck and then reversing the direction downward using fingertips in a raking fashion; massaging the lower back from the backbone across the waistline using the heel of the palm to make large circles; long gliding strokes from the hip up and over the shoulder (Nair ,. 2020 ; El-Hosary et al,. 2019). Back massage will be done in four sessions each session takes 10 minutes and will be performed every week. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Pregnant women aged 20-35 years.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Self-affirmation versus back massageSelf-affirmation is non-pharmacological intervention which represents structured sentences to convey to the subconscious mind to help in reprogramming negative thoughts into positive ones. Massage is defined as systematic touch of soft tissues for therapeutic purposes, such as pain relief, increased comfort and patient's relaxation | Behavioural | Group 2, Group I |
Primary outcome
Psychological Distress
Time frame: 2 months
The Kessler Psychological Distress Scale (K10) is a simple measure of psychological distress (Kessler et al., 2003). The K10 scale involves 10 questions about emotional states each with a five-level response scale. The measure can be used as a brief screen to identify levels of distress
Fear of childbirth
Time frame: 2 months
The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) is a standardized screening method for measuring fear of childbirth during pregnancy (Wijma et al., 1998).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-affirmation versus back massage in people with Self-affirmation, Back Massage, run by Alexandria University at 1 site in Egypt.
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 0 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 1 Jun 2023. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Distress (time frame: 2 months). 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 1 Jun 2023.