NCT04409938

Brief Summary

Background: The aim of this study was to determine the effect of PMR and nature sounds on nursing students' BPM skills, and anxiety levels and vital signs. Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR+NS participants practiced PMR accompanied by nature sounds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

Same day

First QC Date

May 21, 2020

Last Update Submit

August 28, 2020

Conditions

Keywords

Skill trainingNursing studentsAnxietyBlood Pressure Measurement Skills

Outcome Measures

Primary Outcomes (1)

  • The State-Trait Anxiety Inventory (STAI)

    The STAI consists of two parts; the State Anxiety Inventory (SAI) and the Trait Anxiety Inventory (TAI). The SAI measures anxiety about an event while the TAI measures anxiety level as a personal characteristic. The TAI and SAI each consists of 20 items. The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= never, 2= sometimes, 3= often, 4= always). The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= almost never, 2= sometimes, 3= often, 4= almost always). Ten SAI items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) and six TAI items (1, 6, 7, 13, 16, and 19) are reverse scored. Higher scores indicate greater anxiety.

    pre-intervention

Secondary Outcomes (2)

  • The State Anxiety Inventory (SAI)

    through study completion for each group, an average of 4 hour

  • The Blood Pressure Knowledge Test (BPKT)

    through study completion for each group, an average of 4 hour

Study Arms (3)

Progressive Muscle Relaxation

EXPERIMENTAL

PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention.

Other: Progressive Muscle Relaxation

Progressive Muscle Relaxation with Nature Sounds

EXPERIMENTAL

PMR+NS participants practiced PMR accompanied by nature sounds.

Other: Progressive Muscle RelaxationOther: Nature Sounds

Standard Practice

NO INTERVENTION

The standard practice of the lab was made.

Interventions

PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.

Progressive Muscle RelaxationProgressive Muscle Relaxation with Nature Sounds

PMR+NS participants practiced PMR accompanied by nature sounds. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.

Progressive Muscle Relaxation with Nature Sounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being a first-year nursing student
  • voluntary
  • participating in the theoretical part of the "Pulse and Blood Pressure Measurement" course and in lab practice.

You may not qualify if:

  • not participating in the theoretical part of the "Pulse and Blood Pressure Measurement" course and in lab practice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sevda Korkut, PhD

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Inverstigator

Study Record Dates

First Submitted

May 21, 2020

First Posted

June 1, 2020

Study Start

February 3, 2020

Primary Completion

February 3, 2020

Study Completion

February 28, 2020

Last Updated

August 31, 2020

Record last verified: 2020-08

Locations