The Effect of Mindfulness-Based Web-Based Stress Reduction Program Applied to Primigravidas on Perceived Stress Level in Pregnancy, Birth Self-Efficacy and Prenatal Attachment

NCT06316518 | Not Yet Recruiting

• 1 other identifier: AIBU-HF-YS-01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to investigate the effect of a mindfulness-based web-based stress reduction program applied to primigravidas on perceived stress level in pregnancy, birth self-efficacy and prenatal attachment.

Conditions

Pregnancy Related

Keywords

Self Efficacy; Mindfulness; pregnancy; Stress,

Outcome Measures

Primary Outcomes (3)

• Pregnancy Stress Assessment Scale (PSAS)

  The initial scale consisting of 40 items was revised as 36 items as a result of the validity and reliability study conducted in Taiwan. The scale consists of seven (7) sub-dimensions and is 5-point Likert type. Each item is evaluated as (absolutely no (0), mild (1), moderate (2), severe (3), very severe (4)). The lowest score that can be obtained from the scale is 0 and the highest score is 144.

  Two months

• Self-Efficacy Scale for Normal Childbirth

  There are 9 items in the scale. For each item in the scale, scores from 0 to 10 are given and scored as 0 points = no confidence at all and 10 points = very confident. The lowest score that can be obtained from the Self-Efficacy Scale for Normal Birth is 0, while the highest score that can be obtained is 90. As the scores obtained from the self-efficacy scale increase, the degree of self-efficacy also increases.

  Two months

• Prenatal Attachment Inventory (PAI)

  The inventory consists of 21 items and is four-point Likert type. The items of the inventory are scored between 1 and 4 points as 1-Never, 2-Sometimes, 3-Frequently, 4-Always. A minimum of 21 and a maximum of 84 points can be obtained from the inventory. An increase in the score obtained from the inventory indicates an increase in the level of attachment.

  Two months

Study Arms (2)

Mindfulness group

EXPERIMENTAL

Primigravidas randomly assigned to the experimental group will be given web-based mindfulness-based stress reduction trainings after pre-tests are applied.

Other: mindfulness group

control group

ACTIVE COMPARATOR

After the pre-tests were applied to the control group, routine nursing care will be given and post-test measurements will be made after 8 weeks.

Other: mindfulness group

Interventions

mindfulness group OTHER

In the study, primigravidas will receive 8-module (8-week-long) trainings, each lasting approximately 45 minutes, 3 days a week.

Mindfulness group; control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Graduated from at least primary school
• Having a computer or a cell phone,
• Having access to the Internet,
• Being between the ages of 18-35,
• Being 18-24 weeks pregnant,
• Having a single healthy fetus,
• Being primigravida,
• Not having a risky pregnancy (such as placenta previa, preeclampsia, not having any systemic disease),
• Not participating in any childbirth preparation class
• Not having a neurological or psychiatric disease.

You may not qualify if:

• Voluntary withdrawal from the study
• Failure to complete the 8-module training for any reason
• Interruption of internet access and inability to communicate
• Termination of pregnancy for any reason
• Non-participation in the trainings given in the experimental group

Sponsors & Collaborators

• Ataturk University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups with a supportive care control groups

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03