Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies

• Sponsor: Nursel Alp Dal (Other)
• Overall Status: Completed
• CT.gov ID: NCT05021289
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 43.8

Study Details

Study Description

Brief Summary

This research was conducted to identify the effect of the practice of Guided Imagery on the perceived stress level in high-risk pregnancies.

Condition or Disease	Intervention/Treatment	Phase
High Risk Pregnancy	Behavioral: guided imagery	N/A

Detailed Description

Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).
• Masking: Single (Participant)
• Masking Description: care provider
• Primary Purpose: Supportive Care
• Official Title: Effect of the Practice of Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies: Randomized Single-Blind Trial
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: Feb 1, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guided İmagery • participants were given one session of guided imagery.	Behavioral: guided imagery; guided imagery
No Intervention: control group No intervention was applied on the control group patients.

Outcome Measures

Primary Outcome Measures

1. Perceived Stress Scale. [• The first practice of guided imagery was performed face-to-face with pregnant women. At the end of 20 minutes, the pregnant women's stress levels were reevaluated by using the Perceived Stress Scale.]

   Evaluation of the stress level of pregnant women with the Perceived Stress Scale. Comprised of 14 items in total, the scale was designed to measure the extent to which circumstances in one's life are perceived as stressful. The respondents evaluate the items based on a five-point Likert scale that is scored from '0: Never' to '4: Very Often'. Seven positively-stated items are reverse scored. The minimum and maximum scores to be obtained from the scale are successively 0 and 56 points. A high score obtained from the scale indicates that the respondent has high-level stress perception.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:• Having a high-risk pregnancy

• Being aged 18 years or above

• Agreeing to participate in the study

• Being literate in Turkish

Exclusion Criteria:

• The pregnant women who voluntarily wanted to leave the research at any stage after being included in the study, could not communicate verbally, had a visual or hearing disorder, and were previously diagnosed with a psychiatric disease were excluded from the research

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Munzur University	Tunceli	Merkez	Turkey	62002

Sponsors and Collaborators

• Nursel Alp Dal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nursel Alp Dal, Assistant Professor, Munzur University
• ClinicalTrials.gov Identifier: NCT05021289
• Other Study ID Numbers: MunzurUn
• First Posted: Aug 25, 2021
• Last Update Posted: Aug 31, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nursel Alp Dal, Assistant Professor, Munzur University: Guided Imagery; Perceived Stress Level; High-Risk Pregnancies.

Study Results

No Results Posted as of Aug 31, 2021